AccessGUDID - DEVICE: NA (05032384005628)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: CT0017B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OXOID LIMITED

Primary DI Number: 05032384005628
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 365355452 *Terms of Use

Device Description: No description.

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?
45736	Colistin sulfate susceptibility testing disc IVD	A susceptibility testing disc impregnated with a defined amount of the antimicrobial colistin sulfate, intended to be used to determine the antimicrobial susceptibility of a specific microorganism isolated from a clinical specimen by culture, using a disc diffusion method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JTN	Susceptibility Test Discs, Antimicrobial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K860153	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dbe9a95a-2288-403f-80f9-f97f8340d35b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016

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: 05032384502042 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: +441256694238
Email: oxoid.techsupport@thermofisher.com

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