AccessGUDID - DEVICE: BD BBL™ Port-A-Cul™ Vial Sterile Pack (30382902216095)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Port-A-Cul™ Vial Sterile Pack
Version or Model: 221609
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221609
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902216095
Issuing Agency: GS1
Commercial Distribution End Date: June 18, 2024
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Vial Transport Sterile Port-A-Cul 10 Ea

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: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: a6f4575a-1199-40ea-ab2d-7979494a8bd8
Public Version Date: July 17, 2024
Public Version Number: 3
DI Record Publish Date: May 25, 2018