AccessGUDID - DEVICE: Halyard (10680651136296)

GUDID

Device Identifier (DI) Information

Brand Name: Halyard
Version or Model: 13629
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS6504-A
Company Name: Avanos Medical, Inc.

Primary DI Number: 10680651136296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: ON-Q* Pain Relief System with SILVERSOAKER* Antimicrobial Catheter, 270 ml, 5 ml/hr, 2.5 in./65 mm

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?
47190	Elastomeric infusion pump kit	A collection of sterile devices designed to enable a healthcare provider or patient to perform infusion therapy using an elastomeric infusion pump. The kit typically consists of the infusion pump and other devices such as a catheter, tunneller, needle, sheath, syringe, dressings, adhesive strips, and a filling device for the infusion pump. This device is typically used for the infusion of fluids, antibiotics, chemotherapeutic agents, or pain management medications in the healthcare facility or the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEB	PUMP, INFUSION, ELASTOMERIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063530	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d85d87b9-4dc4-4da8-a087-971c00d7e1ef
Public Version Date: November 16, 2018
Public Version Number: 4
DI Record Publish Date: February 27, 2017