AccessGUDID - DEVICE: STATSTRIP (00385480475525)

GUDID

Device Identifier (DI) Information

Brand Name: STATSTRIP
Version or Model: Lactate
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 47552
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480475525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: Nova StatStrip LAC Linearity, Level 1, Level 2, Level 3, Level 4

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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Lactate IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of lactate in a clinical specimen.

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112955	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
Special Storage Condition, Specify: Do not freeze.
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 93f97d57-5723-4aea-a41c-d06e78d40204
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016