AccessGUDID - DEVICE: FMH RapidScreen (10888234000907)

GUDID

Device Identifier (DI) Information

Brand Name: FMH RapidScreen
Version or Model: 0007893
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0007893
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234000907
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells in D-negative mothers.

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:	No
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?
55978	Foeto-maternal haemorrhage/Kleihauer test 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 qualitative and/or quantitative detection of foetal red blood cells in a maternal clinical specimen, also known as a Kleihauer test, as an indicator of foeto-maternal haemorrhage.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIM	Test, Screening, For D Positive Fetal Rbc'S

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK110067	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 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a817b957-8d35-4fd8-9d8e-edfe60e506d6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 14, 2016