AccessGUDID - DEVICE: ON-Q* Pain Relief System with SOAKER* Catheter (00193494000134)

GUDID

Device Identifier (DI) Information

Brand Name: ON-Q* Pain Relief System with SOAKER* Catheter
Version or Model: PS6506-N
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS6506-N
Company Name: Avanos Medical, Inc.

Primary DI Number: 00193494000134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *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":	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?
47205	Cardiac pulse generator programmer	An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.	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: 14fdcf40-add0-45ff-8b9f-600f9869e6e1
Public Version Date: July 03, 2023
Public Version Number: 1
DI Record Publish Date: June 23, 2023