AccessGUDID - DEVICE: Remel (00848838058110)

GUDID

Device Identifier (DI) Information

Brand Name: Remel
Version or Model: R8311004
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REMEL, INC.

Primary DI Number: 00848838058110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 065769564 *Terms of Use

Device Description: RapID SS/u System KT/20

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?
62908	Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple pathogens associated with urinary tract infection, isolated by culture from a clinical specimen, and requiring less incubation time than standard laboratory methods. Organisms may include (but are not limited to) Escherichia coli, Proteus mirabilis, Klebsiella, Staphylococcus aureus, and Candida albicans.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSS	Kit, Identification, Enterobacteriaceae

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: fa527fa1-4538-4476-8ead-df1ee35d489f
Public Version Date: December 08, 2021
Public Version Number: 2
DI Record Publish Date: November 12, 2021

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: 30848838058111 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

[?]

Phone: 8002556730
Email: csemail@thermofisher.com

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