AccessGUDID - DEVICE: Isotemp™ (00815773020557)

GUDID

Device Identifier (DI) Information

Brand Name: Isotemp™
Version or Model: IUEC25286LA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IUEC25286LA
Company Name: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC

Primary DI Number: 00815773020557
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791530061 *Terms of Use

Device Description: IUEC25286LA, Chest ULT 12.7 cu. ft., 115V, 60Hz

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
40513	Ultralow-temperature laboratory freezer	A mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from -40 to -90? Celsius. It will typically have a corrosion resistant (typically stainless steel) interior minimizing the risk of adulteration, contamination, and/or corrosion of the contents and a shelving configuration appropriate for storage/easy localization of the products. It will typically be programmable, have defrost capabilities, a built-in alarm system to warn against temperature variations, and a recorder to record events.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSE	Refrigerator, Freezer, Blood Storage

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c6ae776-7fc2-4afa-bc2b-9719767cf74c
Public Version Date: December 09, 2022
Public Version Number: 1
DI Record Publish Date: December 01, 2022