FDA.reportPublic FDA data

ambIT* Cassette - Filter, Spike with Yellow Striped Tubing

Primary DI
00193494001100
Brand
ambIT* Cassette - Filter, Spike with Yellow Striped Tubing
Company
Avanos Medical, Inc.
Model
220517Y
Catalog number
220517Y
Device description
ambIT* Cassette - Filter, Spike with Yellow Striped Tubing, and Neuraxial Connector
Published
2022-01-17
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
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193494001107PackageGS110In Commercial Distribution
20193494001104PackageGS12In Commercial Distribution
00193494001100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019349400110710193494001107
2019349400110420193494001104
00193494001100001934940011001934940011000193494001100

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.

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651135718Halyard13571PM0062016-08-10
10680651136128Halyard13612PM0022016-08-10
10680651136135Halyard13613PM0032016-08-10
10680651136142Halyard13614PM0042016-08-10
10680651136159Halyard13615PM0052016-08-10
00193494135713ON-Q* Pain Relief System13571PM0062020-05-07
00193494136123ON-Q* Pain Relief System13612PM0022020-05-07
00193494136130ON-Q* Pain Relief System13613PM0032020-05-07
00193494136147ON-Q* Pain Relief System13614PM0042020-05-07
00193494136154ON-Q* Pain Relief System13615PM0052020-05-07
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15

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