AccessGUDID - DEVICE: Cyanmethemoglobin Standard (20 gm/dL @ 1:251 DILUTION) (00657498001158)

GUDID

Device Identifier (DI) Information

Brand Name: Cyanmethemoglobin Standard (20 gm/dL @ 1:251 DILUTION)
Version or Model: 0325-006
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0325-006
Company Name: STANBIO LABORATORY, L.P.

Primary DI Number: 00657498001158
Issuing Agency: GS1
Commercial Distribution End Date: August 24, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 045361136 *Terms of Use

Device Description: For the Quantitative Colorimetric Determination of Hemoglobin in Whole Blood.

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:	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?
32430	Cyanomethemoglobin kit	A test system consisting of one or multiple reagents and other items intended to measure the concentration of cyanomethemoglobin in a biological sample. Measurements are used to determine the concentration of haemoglobin for the detection of anaemia.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GJZ	Cyanomethemoglobin Reagent And Standard Solution

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fbf75505-0ab8-4074-aee4-164a1e757b3e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016