AccessGUDID - DEVICE: Research and Diagnostic Systems (00815762021022)

GUDID

Device Identifier (DI) Information

Brand Name: Research and Diagnostic Systems
Version or Model: HCLNH3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HCLNH3
Company Name: RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Primary DI Number: 00815762021022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 087248183 *Terms of Use

Device Description: R&D Hemocue Glu/Hgb: 3 x 1.5mL (one of each level)

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?
52856	Glucose/haemoglobin (Hb) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose and haemoglobin (Hb) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGM	Control, Hemoglobin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993321	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
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: 4.5 Milliliter

Device Record Status

Public Device Record Key: e62b8715-fc77-46f1-85ca-eff5f205295c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 29, 2016