AccessGUDID - DEVICE: BD™ Universal Viral Transport Combo Kit (30382902202227)

GUDID

Device Identifier (DI) Information

Brand Name: BD™ Universal Viral Transport Combo Kit
Version or Model: 220222
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 220222
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902202227
Issuing Agency: GS1
Commercial Distribution End Date: June 22, 2021
Device Count: 50
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Kit Universal Viral Transport Combo Swab

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:	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?
62773	General specimen collection kit IVD, clinical	A collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSM	CULTURE MEDIA, NON-PROPAGATING TRANSPORT

FDA Premarket Submission

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

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 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: 2dc704e6-d741-4642-8477-69dc134ddee3
Public Version Date: November 09, 2022
Public Version Number: 3
DI Record Publish Date: May 25, 2018