AccessGUDID - DEVICE: STAT PROFILE (00385480534208)

GUDID

Device Identifier (DI) Information

Brand Name: STAT PROFILE
Version or Model: PRIME CCS COMP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 53420
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480534208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: Remanufactured PRIME CCS Comp Analyzer

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56672	Blood gas/haemoximetry analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGA	GLUCOSE OXIDASE, GLUCOSE
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JJS	CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
GKF	INSTRUMENT, HEMATOCRIT, AUTOMATED
KHP	ACID, LACTIC, ENZYMATIC METHOD
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JGS	ELECTRODE, ION SPECIFIC, SODIUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141907	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 32 Degrees Celsius
Special Storage Condition, Specify: 0 ft to 12000 ft
Special Storage Condition, Specify: Without Condensation
Storage Environment Temperature: between 15 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ead787f-c363-4b55-910c-26ea3af14706
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 06, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10385480534205	1	00385480534208		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)545-6682
Email: info@novabio.com

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