AccessGUDID - DEVICE: Bromelin for Erytype (07611969965755)

GUDID

Device Identifier (DI) Information

Brand Name: Bromelin for Erytype
Version or Model: 806210100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 806210100
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969965755
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: Red Blood Cell Diluent for TANGO instruments, 10x10 mL

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):	Yes
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?
52709	Bromelin immunohaematology reagent IVD	A substance or reactant that is a bromelin enzyme solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSZ	System, Test, Automated Blood Grouping And Antibody

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK040070	0

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4345a91c-5ae1-4a63-85c9-bbee7f92c422
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 14, 2017