FDA.reportPublic FDA data

ON-Q* C-bloc Intl Pain Relief System

Primary DI
00193494134792
Brand
ON-Q* C-bloc Intl Pain Relief System
Company
Avanos Medical, Inc.
Model
13479
Catalog number
CBI002
Device description
ON-Q* Pump Fixed Flow
Published
2020-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEBPump, infusion, elastomeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEBPump, Infusion, ElastomericGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063530000ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMPI-Flow Corp.2007-01-26MEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193494134799PackageGS15In Commercial Distribution
00193494134792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019349413479910193494134799
00193494134792001934941347921934941347920193494134792

GMDN Terms#

Term, Definition table
TermDefinition
Elastomeric infusion pump systemAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume400Milliliter

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770008998100mL ENFit GPro Syringe Purple Sterile120008323PNM-S100NCV2026-10-19
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1200011280630-142026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1200011290630-202026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1200014300630-242026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1095814020630-142026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014310640-142026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014320640-202026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014330640-242026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014340644-142026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014350644-202026-10-14
00350770997889MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014360644-242026-10-14
00350770997926MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014370645-142026-10-14
00350770997933MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1200014380645-202026-10-14
00350770997940MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 24 Fr, PULL1200014390645-242026-10-14
00350770997957MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095831020645-142026-10-14
00193493000753GenVisc 850 Sodium Hyaluronate50653-0006-0150653-0006-012024-03-06
00193493000760TriVisc Sodium Hyaluronate50653-0006-0450653-0006-042024-03-06
00850653006016GenVisc® 850 sodium hyaluronate50653-0006-012016-10-31
00850653006047TriVisc™ sodium hyaluronate50653-0006-042018-12-20
10680651467185Halyard46718N589132017-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18859299151073SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-10-06
18859299150984SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-23
18859299151080SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-23
18859299151097SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-23
18859299151103SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-23
18859299175079SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-04
18859299175178SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-04
18859299175185SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-04
18859299175192SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-04
10612479280189McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280202McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280226McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280240McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280264McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280288McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280301McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280325McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280349McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280363McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280387McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280400McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280424McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280448McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280462McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479271323McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271347McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271361McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271385McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271408McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271422McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20