AccessGUDID - DEVICE: Onyx Disposable A-W Syringe Tips (00723896019641)

GUDID

Device Identifier (DI) Information

Brand Name: Onyx Disposable A-W Syringe Tips
Version or Model: 7158211
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7158211
Company Name: PRACTICON, INC.

Primary DI Number: 00723896019641
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Black Air/Water Syringe Tips

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?
62258	Oral/enteral syringe drawing-up straw	A flexible, blunt, tubular device intended to be connected to an oral/enteral syringe for the convenient transfer of fluids (e.g., dissolved medication, liquid nutrition) from an open container into the syringe prior to oral/enteral administration; it is not intended to puncture the seal of a vial/container, nor is it intended for patient contact. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECB	Unit, Syringe, Air And/Or Water

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: fec354d6-2836-46a2-81d7-91b9fc5cfcbd
Public Version Date: April 08, 2022
Public Version Number: 2
DI Record Publish Date: July 23, 2021