AccessGUDID - DEVICE: Research and Diagnostic Systems (10815762021746)

GUDID

Device Identifier (DI) Information

Brand Name: Research and Diagnostic Systems
Version or Model: FH1032
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FH1032
Company Name: RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Primary DI Number: 10815762021746
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 087248183 *Terms of Use

Device Description: FETALtrol 3 x 2 mL (Level 2)

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):	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?
55975	Foeto-maternal haemorrhage/Kleihauer test IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)	A collection of reagents and other associated materials intended to be 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 using a fluorescent activated cell sorting/flow cytometry (FACS/Flow) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JPK	Mixture, Hematology Quality Control

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
Handling Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 6 Milliliter

Device Record Status

Public Device Record Key: 4e6c9fbf-9958-4eb4-b5a8-1fc1f3127485
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 03, 2016