AccessGUDID - DEVICE: Puritan Opti-Swab (30609576900892)

GUDID

Device Identifier (DI) Information

Brand Name: Puritan Opti-Swab
Version or Model: CB-206 (25-3506-H)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CB-206 (25-3506-H)
Company Name: Puritan Medical Products

Primary DI Number: 30609576900892
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 001101419 *Terms of Use

Device Description: Puritan Fecal Opti-Swab Collection & Transport System

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?
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. 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: Yes
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: 21aa047b-6ca4-4d25-be90-fa4c59c585ea
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022