DEVICE: ON-Q* C-Bloc with SELECT-A-FLOW* and ONDEMAND* (00193494134730)

Device Identifier (DI) Information

ON-Q* C-Bloc with SELECT-A-FLOW* and ONDEMAND*
13473
In Commercial Distribution
CB005
Avanos Medical, Inc.
00193494134730
GS1

1
079375431 *Terms of Use
ON-Q* C-Bloc with SELECT-A-FLOW* and ONDEMAND*, 400 ml x 1-7 +5 ml bolus/60 min
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MEB Pump, infusion, elastomeric
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K063530 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Balloon Fill Volume (ml)
Total Volume: 400 Milliliter
CLOSE

Device Record Status

dbd9801b-15ab-4334-be94-ba2de7176a01
June 23, 2023
2
July 03, 2020
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10193494134737 5 00193494134730 In Commercial Distribution CS
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(844)428-2667
PIQ@AVANOS.COM
CLOSE