FDA.reportPublic FDA data

AVANOS

Primary DI
00193494298814
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
7000188
Catalog number
7000188
Device description
OnQ Pain Relief System
Published
2020-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10193494298811PackageGS15In Commercial Distribution
00193494298814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019349429881110193494298811
00193494298814001934942988141934942988140193494298814

GMDN Terms#

Term, Definition table
TermDefinition
Elastomeric infusion pump kitA 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.

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10612479271446McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271460McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271484McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271507McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271521McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271545McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
08436020766404DOSI-PAINLEVENTON SAUMEB2018-12-31
08436020766411DOSI-PAINLEVENTON SAUMEB2018-12-31
08436020766428DOSI-PAINLEVENTON SAUMEB2018-12-31