AccessGUDID - DEVICE: MicroScan (15099590657536)

GUDID

Device Identifier (DI) Information

Brand Name: MicroScan
Version or Model: B1017-212
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590657536
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: Pos MIC Panel Type 29

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:	Yes
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58605	General-microorganism antimicrobial susceptibility culture medium IVD	A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LTW	Susceptibility Test Cards, Antimicrobial
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
JWY	Manual Antimicrobial Susceptibility Test Systems
LTT	Panels, Test, Susceptibility, Antimicrobial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003619	000
K010418	000
K020160	000
K020162	000
K043545	000
K050043	000
K051202	000
K081013	000
K081182	000
K091264	000
K862140	000
K863776	000
K870074	000
K874876	000
K883076	000
K934323	000
K945235	000
K972688	000
K972799	000
K993102	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: d5ee5eda-96f3-4c72-9ff7-b2745e55217b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 02, 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: 05099590657539 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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