AccessGUDID - DEVICE: Thermogenesis BioArchive (00886368000582)

GUDID

Device Identifier (DI) Information

Brand Name: Thermogenesis BioArchive
Version or Model: 8-4000-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thermogenesis Corp.

Primary DI Number: 00886368000582
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080690327 *Terms of Use

Device Description: BioArchive Device 220V

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:	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
OAO	Cord Blood Processing System And Storage Container

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
Storage Environment Temperature: between 15 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4f535d42-d0a2-4f63-b8f8-04aeea8b4b47
Public Version Date: October 11, 2021
Public Version Number: 1
DI Record Publish Date: October 01, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: Yes
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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 916-858-5100
Email: customerservice@thermogenesis.com

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