AccessGUDID - DEVICE: ON-Q* Pain Relief System with SELECT-A-FLOW* (00193494134761)

GUDID

Device Identifier (DI) Information

Brand Name: ON-Q* Pain Relief System with SELECT-A-FLOW*
Version or Model: 13476
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CB6004
Company Name: Avanos Medical, Inc.

Primary DI Number: 00193494134761
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 SELECT-A-FLOW*, 600 ml, 2-14 ml/hr

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
46542	Elastomeric infusion pump system	An assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in 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
Total Volume: 600 Milliliter
Device Size Text, specify: Balloon Fill Volume (ml)

Device Record Status

Public Device Record Key: dbad7952-626f-4a4f-b8f6-cd9eba6b9de7
Public Version Date: June 23, 2023
Public Version Number: 2
DI Record Publish Date: July 03, 2020