AccessGUDID - DEVICE: REMEL (00848838023385)

GUDID

Device Identifier (DI) Information

Brand Name: REMEL
Version or Model: R21243
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R21243
Company Name: REMEL, INC.

Primary DI Number: 00848838023385
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 065769564 *Terms of Use

Device Description: Nitrate Reagent A for AFB BTL/25ml

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:	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?
35841	Nitrate reduction microbial reagent IVD	One or multiple substances or reactants intended to be used in microbial testing to detect nitratase enzyme production, by demonstrating the reduction of nitrate through a visible colour change in an organism isolated from a clinical specimen by culture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	Discs, Strips And Reagents, Microorganism Differentiation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 89f72087-35ab-48ae-b1b4-8b5ef2f9eaba
Public Version Date: April 02, 2025
Public Version Number: 2
DI Record Publish Date: January 03, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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