AccessGUDID - DEVICE: STAT-Site M Hgb Cards (00657498000151)

GUDID

Device Identifier (DI) Information

Brand Name: STAT-Site M Hgb Cards
Version or Model: 901025
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 901025
Company Name: STANBIO LABORATORY, L.P.

Primary DI Number: 00657498000151
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2019
Device Count: 100
Labeler D-U-N-S® Number*: 045361136 *Terms of Use

Device Description: The Stanbio STAT-Site® MHgb Test Kit is intended for the quantitative determination of hemoglobin in whole blood using the Stanbio STAT-Site® MHgb Meter. The STAT-Site® MHgb Test may be used with adults, infants, and children in a physician’s office or other professional point-of-care setting.

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:	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?
32435	Haemoglobin analyser IVD, point-of-care	A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHG	Whole Blood Hemoglobin Determination

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 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f204c207-a150-4c4a-9f9c-957d96ad3595
Public Version Date: April 01, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2016