AccessGUDID - DEVICE: PRAS Indole Nitrate Broth (00810048901098)

GUDID

Device Identifier (DI) Information

Brand Name: PRAS Indole Nitrate Broth
Version or Model: AS-861
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS-861
Company Name: ANAEROBE SYSTEMS

Primary DI Number: 00810048901098
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 021192653 *Terms of Use

Device Description: AS-861 Indole Nitrate Broth is a nonselective broth used for the detection of indole production and nitrate reduction by a microorganism. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent light 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?
34018	Indole broth/peptone water microbial reagent IVD	A substance or reactant, sometimes referred to as indole broth or peptone water, intended to be used in the testing of a microorganism isolated from a clinical specimen by culture, to detect the presence of enzymes that split indole from the amino acid tryptophan.	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: 0d4395aa-e4bc-4104-9a65-d5837cda3e3c
Public Version Date: May 11, 2020
Public Version Number: 1
DI Record Publish Date: May 01, 2020