AccessGUDID - DEVICE: Saline Solution (0.85%) (B08816120)

GUDID

Device Identifier (DI) Information

Brand Name: Saline Solution (0.85%)
Version or Model: 1612
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11-612-001
Company Name: BIO-MED DIAGNOSTICS, INC.

Primary DI Number: B08816120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 605213545 *Terms of Use

Device Description: Saline Solution (0.85%) is a saline solution for viral specimens.

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?
58673	Saline suspension medium/diluent IVD	A saline solution intended to be used as a non-enriching diluent or suspension medium for microorganisms isolated from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSG	Culture Media, Non-Selective And Non-Differential

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 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 43e96a2f-6d14-426e-b57b-7197a286d9f9
Public Version Date: February 21, 2022
Public Version Number: 2
DI Record Publish Date: September 29, 2020