AccessGUDID - DEVICE: AIMSTRIP HEMOGLOBIN STARTER KIT 200 (00695684782009)

GUDID

Device Identifier (DI) Information

Brand Name: AIMSTRIP HEMOGLOBIN STARTER KIT 200
Version or Model: 78200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GERMAINE LABORATORIES, INC

Primary DI Number: 00695684782009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 176458115 *Terms of Use

Device Description: For testing 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:	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?
55873	Total haemoglobin (totHb) IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen, using an enzyme spectrophotometry method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KHG	Whole Blood Hemoglobin Determination
GIG	Hemoglobinometer

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8eefc48a-c057-4846-8dca-97e9e20c706e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 11, 2016