FDA.reportPublic FDA data

ARROW

Primary DI
30801902097911
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN032604
Catalog number
AI-07000
Device description
Catheter Hemostasis Valve For Use with .038" (.096 cm) Dia. and Smaller Guide Wires
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30801902097911PackageGS150In Commercial Distribution
00801902097910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3080190209791130801902097911
00801902097910008019020979108019020979100801902097910

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04048223129456EpiLong TuohyPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223133385EpiSpin LockPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223133392EpiSpin LockPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223128190SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128206SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128244StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128312SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128343PlexoLong NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128398SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128404SonoLong Curl EchoPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128435PlexoLong Sono NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128527SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128558StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128565SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128589SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128596SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128602SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128626PlexoLong Sono NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128633StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128640SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128664SonoLong Curl EchoPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128688SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128701SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128725StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128749StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128756StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128763StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128787StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128800StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17