FDA.reportPublic FDA data

ambIT* Introducer - Beveled Tip, Peelable Sheath

Primary DI
00193494000615
Brand
ambIT* Introducer - Beveled Tip, Peelable Sheath
Company
Avanos Medical, Inc.
Model
220418
Catalog number
220418
Device description
ambIT* Introducer - Beveled Tip, Peelable Sheath
Published
2022-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSOCATHETER, CONDUCTION, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102460000AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATHSummit Medical Products, Inc.2011-01-13BSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193494000619PackageGS110In Commercial Distribution
00193494000615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2019349400061920193494000619
00193494000615001934940006151934940006150193494000615

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous cannulaA short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. 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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902197631ARROWTELEFLEX INCORPORATEDBSO2022-11-09
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10801902200614ARROWTELEFLEX INCORPORATEDBSO2022-11-09
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10801902201468ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902192636ARROWTELEFLEX INCORPORATEDBSO2022-11-08
10801902194579ARROWTELEFLEX INCORPORATEDBSO2022-11-08
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10801902207484ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207521ARROWTELEFLEX INCORPORATEDBSO2022-09-14
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10801902207699ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207705ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207712ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207811ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207620ARROWTELEFLEX INCORPORATEDBSO2022-07-07
10801902207507ARROWTELEFLEX INCORPORATEDBSO2022-05-13
10801902207835ARROWTELEFLEX INCORPORATEDBSO2022-05-11
10801902207569ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207682ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207743ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207842ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207446ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207668ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207736ARROWTELEFLEX INCORPORATEDBSO2022-04-11