AccessGUDID - DEVICE: RESOLVE Systems Neonatal Hemoglobin Kit (06438147000791)

GUDID

Device Identifier (DI) Information

Brand Name: RESOLVE Systems Neonatal Hemoglobin Kit
Version or Model: FR-9360
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FR-9360
Company Name: Wallac Oy

Primary DI Number: 06438147000791
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: For detection of normal and variant hemoglobins.

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:	Yes
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?
55876	Multiple haemoglobin subtype IVD, kit, electrophoresis	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of multiple subtypes of haemoglobin in a clinical specimen, using an electrophoresis method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKA	Abnormal Hemoglobin Quantitation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050709	000

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: bf64df6a-7b42-41b6-a94b-6873b994dc60
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: February 02, 2016