AccessGUDID - DEVICE: Quantum® (05020583210202)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum®
Version or Model: 21020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TERUMO BCT, INC.

Primary DI Number: 05020583210202
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 801679200 *Terms of Use

Device Description: Quantum System Cell Expansion Set and Accessories, Cell Inlet Bag 0.5 L, Accessory Set

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:	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?
44904	Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KJF	SYSTEM, SUSPENSION, CELL CULTURE

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep out of sunlight.
Storage Environment Temperature: between 2 and 40 Degrees Celsius
Special Storage Condition, Specify: Protect from rain

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8894d53b-758a-4053-b57a-9e7700c11f50
Public Version Date: May 27, 2024
Public Version Number: 7
DI Record Publish Date: September 15, 2016