AccessGUDID - DEVICE: Worksafe™ Blood Culture Collection Kits: FAN®PLUS Combo (03573026606473)

GUDID

Device Identifier (DI) Information

Brand Name: Worksafe™ Blood Culture Collection Kits: FAN®PLUS Combo
Version or Model: Worksafe™ Blood Culture Collection Kits: FAN®PLUS Combo
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX , INC.

Primary DI Number: 03573026606473
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086785110 *Terms of Use

Device Description: BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Aerobic and Standard Anaerobic Bottles.

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:	Yes
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?
58543	Blood culture broth kit IVD	A collection of two or more bottles containing broth culture medium, with or without additional supplements and/or adsorbent compounds, intended to be used for the collection, preservation, and/or transport of a clinical blood specimen for culture, analysis, and/or other investigation using a manual or automated method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OIB	Blood and urine collection kit (excludes HIV testing)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0490bd8-e759-4673-9377-4a8c723d2989
Public Version Date: May 13, 2022
Public Version Number: 2
DI Record Publish Date: April 23, 2020