AccessGUDID - DEVICE: BD Copan FLOQSwabs for HPV Self Collection (30382904454365)

GUDID

Device Identifier (DI) Information

Brand Name: BD Copan FLOQSwabs for HPV Self Collection
Version or Model: 445436
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 445436
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382904454365
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Copan FLOQSwabs for HPV Self Collection

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?
57937	Urogenital specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of cellular and/or other material collected from the endocervix, vagina, and other male/female lower urogenital area (e.g., urethra) for in vitro diagnostic investigation [e.g., microbiological culture, histopathological cervical cancer screening]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium (e.g., preservative solution, Amies/Stuart transport medium); initial preparation/fixation/preservation materials may also be included in the kit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MAQ	KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160037	017

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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 08e0da71-fce8-4984-a120-7e938ab47c94
Public Version Date: November 04, 2024
Public Version Number: 2
DI Record Publish Date: October 09, 2024