FDA.reportPublic FDA data

ambIT*

Primary DI
20193494000824
Brand
ambIT*
Company
Avanos Medical, Inc.
Model
220344
Catalog number
220344
Device description
ambIT* Pain Control System - Standard
Published
2022-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
20193494000824PackageGS15In Commercial Distribution
00193494000820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2019349400082420193494000824
00193494000820001934940008201934940008200193494000820

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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