AccessGUDID - DEVICE: DispoSafety Medical Waste, Biohazard Bags with Ties,12 Gal,24" x 25.6",0.78 MIL (00840117339491)

GUDID

Device Identifier (DI) Information

Brand Name: DispoSafety Medical Waste, Biohazard Bags with Ties,12 Gal,24" x 25.6",0.78 MIL
Version or Model: 43200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00840117339491
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: No description.

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":	Yes
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?
66899	Contaminated waste bag	A flexible plastic pouch intended for the safe collection, storage, transportation and disposal of contaminated and/or otherwise hazardous biological materials, typically containing or having been in contact with bodily substances such as blood, sputum, urine, faeces; it is not intended for in vitro diagnostic purposes. It is typically identified with the biohazard symbol on its labelling and may be colour coded. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNY	Basin, Emesis

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b6e48428-8c58-4de9-8687-eb832671c1be
Public Version Date: April 15, 2025
Public Version Number: 1
DI Record Publish Date: April 07, 2025