AccessGUDID - DEVICE: Applicator - Simplex C76 (03573026250768)

GUDID

Device Identifier (DI) Information

Brand Name: Applicator - Simplex C76
Version or Model: 559802
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026250768
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: The Simplex instrument automates placement of up to 6 different Etest strips from foam packaging directly onto agar plates.

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):	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?
62035	Antimicrobial susceptibility strip dispenser IVD	A mains electricity (AC-powered) device intended to be used to position and apply test strips impregnated with antimicrobial agents onto agar plates, or other culture media, for the determination of the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JWY	Manual antimicrobial susceptibility test systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102668	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
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 635405da-aed7-4957-8248-a5014eb9f668
Public Version Date: May 24, 2021
Public Version Number: 2
DI Record Publish Date: April 24, 2020