AccessGUDID - DEVICE: HBSS, w/o CA, MG and PH Red (1X)(CE) (10190302002868)

GUDID

Device Identifier (DI) Information

Brand Name: HBSS, w/o CA, MG and PH Red (1X)(CE)
Version or Model: 14175046
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LIFE TECHNOLOGIES LIMITED

Primary DI Number: 10190302002868
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 229044524 *Terms of Use

Device Description: No description.

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?
58567	Cell culture medium IVD	A liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIP	FORMULATIONS, BALANCED SALT SOLUTIONS

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 72791fec-61b0-477e-8ae0-2b8ee3a6eb88
Public Version Date: April 01, 2024
Public Version Number: 5
DI Record Publish Date: September 03, 2019