FDA.reportPublic FDA data

ambIT* PreSet* Pump (packaged)

Primary DI
00193494000677
Brand
ambIT* PreSet* Pump (packaged)
Company
Avanos Medical, Inc.
Model
220426
Catalog number
220426
Device description
PreSet* Pump (packaged)
Published
2022-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, infusion
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
OFQAnesthesia KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052221000AMBIT PUSH & PLAY AMBULATORY INFUSION PUMPSorenson Medical, Inc.2005-12-08FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193494000677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193494000677001934940006771934940006770193494000677

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose infusion pump, battery-poweredA battery-powered ambulatory device intended to provide continuous or intermittent administration of non-specific drugs and/or solutions. It consists of a small unit with a pumping mechanism and an infusion-rate controller, and is used with a dedicated single-use medication cartridge (not included). It is used with a suitable injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt or carried in a pocket and may be used in a healthcare setting or in the home.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true
Manufacturing date on label
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
10198956454705CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-03
10198956405004CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-01
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
H65857032365Henry ScheinHENRY SCHEIN, INC.OFQ2022-12-12
H65857032105Henry ScheinHENRY SCHEIN, INC.OFQ2022-10-25
H65857032025Henry ScheinHENRY SCHEIN, INC.OFQ2022-09-19
10195594419592CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-05-09
H65857030615Henry ScheinHENRY SCHEIN, INC.OFQ2022-04-29
10195594375423CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594000684CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-01-28
10195594416362CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-01-24
10195594395896CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-01-11
10195594386047CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-01-04
10195594389574CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-12-30
10195594265120CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-12-22
10195594328658CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-12-22
10195594429898CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-12-22
10195594417222CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-12-16
10195594422639CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-12-16
10195594394233CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-12-14
10195594418212CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-12-09
10195594394240CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-12-07
10195594388010CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-12-02
10195594426767CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-11-29
10195594221553CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-11-15
10195594338244CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-11-15
10195594311797CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-11-12
10195594385835CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-11-12
10195594430924CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-11-12
10195594410223CARDINAL HEALTHCardinal Health 200, LLCOFQ2021-11-08