AccessGUDID - DEVICE: RNA (00851290002300)

GUDID

Device Identifier (DI) Information

Brand Name: RNA
Version or Model: Glucose and B-Ketone CVC Level 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70906-01
Company Name: Rna Medical Division

Primary DI Number: 00851290002300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101187037 *Terms of Use

Device Description: Bottle label

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):	No
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?
52852	Glucose/ketone/lipid profile IVD, control	A material which is used to verify the performance of a number of assays intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 0128343a-2bf6-46a9-b783-73dd7620d194
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 04, 2017