AccessGUDID - DEVICE: 2L MC Bottle (08720299213647)

GUDID

Device Identifier (DI) Information

Brand Name: 2L MC Bottle
Version or Model: 2LM-04-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Scinus Cell Expansion Netherlands B.V.

Primary DI Number: 08720299213647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 493047487 *Terms of Use

Device Description: This bottle can be used for the hydration of microcarriers and to reconstitute them in medium. And, the addition of the microcarriers to the Adherent Bag.

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":	Yes
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?
35734	Laboratory liquid dispenser, manual	A manual laboratory device designed to dispense fluid from a stock reservoir (e.g., a bottle or other container). The user determines the intended volume, typically up to 100 ml, by operating a manual pump. This device may be hand-held, or fitted to a bottle or alternative reservoir.	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: Yes

Sterilization Method [?]
Radiation Sterilization

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: 1fbf9f16-3268-4e32-8abf-12ff45e6797b
Public Version Date: January 22, 2021
Public Version Number: 1
DI Record Publish Date: January 14, 2021