AccessGUDID - DEVICE: cobas b 221 S2 Fluid Pack (04015630028092)

GUDID

Device Identifier (DI) Information

Brand Name: cobas b 221 S2 Fluid Pack
Version or Model: 3260925184
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3260925184
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630028092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *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:	Yes
Prescription Use (Rx):	Yes
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?
30210	Multiple blood gas analyte IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 60766d82-f772-4e58-91a4-a1dad0c226e4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 20, 2016