AccessGUDID - DEVICE: MicroScan (15099590657918)

GUDID

Device Identifier (DI) Information

Brand Name: MicroScan
Version or Model: B1017-414
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590657918
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: Neg Urine Combo Panel Type 61

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
LQM	Gram Negative Identification Panel
LTW	Susceptibility Test Cards, Antimicrobial
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
LTT	Panels, Test, Susceptibility, Antimicrobial
JWY	Manual Antimicrobial Susceptibility Test Systems

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: 312e4004-5f0b-4b87-9bd1-d0943b2d5e42
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 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: 05099590657911 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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