AccessGUDID - DEVICE: Sharps container (00842209100026)

GUDID

Device Identifier (DI) Information

Brand Name: Sharps container
Version or Model: 30-0014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30-0014
Company Name: NORTH AMERICAN RESCUE, LLC

Primary DI Number: 00842209100026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832426782 *Terms of Use

Device Description: NAR Sharps Shuttle. A clear container that holds up to 6 needles for safe disposal of sharps. It is designed for point-of-use containment of used needles and small syringes. Item number 30-00146 is a package of 6 Sharps Shuttles. Item number 30-0174 is a package of 200 Sharps Shuttles. Refer to Package DI numbers.

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):	Yes
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?
35429	Sharps container	A hard-walled container designed for the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically by incineration.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMK	Container, Sharps

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152340	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 586fd400-24b9-4f44-9035-dc9930ba27c9
Public Version Date: August 18, 2023
Public Version Number: 8
DI Record Publish Date: September 22, 2016