AccessGUDID - DEVICE: PRAS Peptone Yeast Extract Broth w/ Lactate FA/GLC (PY LACTATE FA/GLC) (00810048901135)

GUDID

Device Identifier (DI) Information

Brand Name: PRAS Peptone Yeast Extract Broth w/ Lactate FA/GLC (PY LACTATE FA/GLC)
Version or Model: AS-846
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AS-846
Company Name: ANAEROBE SYSTEMS

Primary DI Number: 00810048901135
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 021192653 *Terms of Use

Device Description: AS-846 Peptone Yeast Extract Broth with Lactate FA/GLC (PY LACTATE FA/GLC) is designed for the determination of lactate fermentation by anaerobic bacteria for identification. PY LACTATE FA/GLC is recommended for use in identifying Veillonella species within the MIDI MIS procedures. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent golden yellow liquid. 10 tubes per pack.

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):	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?
58586	Basic/simple nutrient broth culture medium IVD	A non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSC	Culture Media, General Nutrient Broth

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 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e3e2e89-c98d-4530-be05-43fb1a086d1c
Public Version Date: December 31, 2021
Public Version Number: 3
DI Record Publish Date: May 01, 2020