AccessGUDID - DEVICE: Pediatric Bilirubin Control Level 2 Set 3x3mL (00896863002301)

GUDID

Device Identifier (DI) Information

Brand Name: Pediatric Bilirubin Control Level 2 Set 3x3mL
Version or Model: 1332-31
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1332-31
Company Name: QUANTIMETRIX CORPORATION

Primary DI Number: 00896863002301
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010717890 *Terms of Use

Device Description: The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin assay methods to validate quantitation of patient samples. It is supplied as a liquid, 3x3mL vials per box. It is prepared from purified bilirubin in a human protein base, stabilizers and preservatives have been added.

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
30215	Total bilirubin IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total bilirubin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K860942	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 Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5223cfc0-2be6-4243-8416-39176e31999d
Public Version Date: October 29, 2018
Public Version Number: 1
DI Record Publish Date: September 26, 2018