AccessGUDID - DEVICE: AXP Disposable Processing Bagset (00886368000308)

GUDID

Device Identifier (DI) Information

Brand Name: AXP Disposable Processing Bagset
Version or Model: 8-5101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thermogenesis Corp.

Primary DI Number: 00886368000308
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080690327 *Terms of Use

Device Description: Cord blood processing system and storage container

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:	Yes
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?
16534	Cryobiological storage container	A super-insulated vessel designed to store cryobiological specimens (frozen tissues/organs), typically with the use of liquid nitrogen (LN2), for an indefinite period. The device is typically designed to store multiple specimens.	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 [?]
BK070006	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: 15 deg C - 30 deg C, Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 62d507a8-f0ab-4595-a2c2-2ccfa4eb48d7
Public Version Date: January 12, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2016