FDA.report

Arterial Needle

Primary DI
20886333208399
Brand
Arterial Needle
Company
ARGON MEDICAL DEVICES, INC.
Model
195315
Catalog number
195315
Device description
AMC/3 Arterial Needle–19ga x 1.5” (3.8cm)
Published
2022-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDFGuide, Needle, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10886333208392PackageGS110In Commercial Distribution
20886333208399PackageGS1150In Commercial Distribution
00886333208395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088633320839210886333208392
2088633320839920886333208399
00886333208395008863332083958863332083950886333208395

GMDN Terms

TermDefinition
Vascular catheter introduction needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags

DUNS number
140727624
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
true
Expiration date on label
true
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 DIBrandModelCatalogPublished
20886333227864V-Stick Vascular Access Set391504300E391504300E2026-03-20
20886333227871V-Stick Vascular Access Set391505300E391505300E2026-03-20
20886333227888V-Stick Vascular Access Set 391505400E391505400E2026-03-20
20886333227895V-Stick Vascular Access Set391604300E391604300E2026-03-20
20886333227901V-Stick Vascular Access Set 391605300E391605300E2026-03-20
20886333227918V- Stick Vascular Access Set391605400E391605400E2026-03-20
20886333227925V-Stick Vascular Access Set391504400E391504400E2026-03-20
20886333227932V-Stick Vascular Access Set391604400E391604400E2026-03-20
20886333209259Tumescent Infiltration Kit1981431981432025-05-02
10886333227584OneStic Micro-Access Introducer4978864978862025-05-02
20886333227116Bone Access NeedleDBANJ0806TLDBANJ0806TL2023-01-03
20886333227659Transfermoral Transcaval Liver Biopsy SystemTF-18CTF-18C2024-08-12
20886333227499ClosureFast GuidewireGW-025-260-1.5JGW-025-260-1.5J2024-07-29
20886333227505ClosureFast GuidewireGW-035-45GW-035-452024-07-29
20886333227512ClosureFast Introducer Sheath IS-7F07IS-7F072024-07-29
20886333227529ClosureFast Introducer Sheath IS-7F11IS-7F112024-07-29
20886333227550ClosureFast Micro Puncture MPK-4FMPK-4F2024-07-29
20886333227567ClosureFast Micro PunctureMPK-5FMPK-5F2024-07-29
20886333227574ClosureFast Tumescent Infiltration KitTIK-01TIK-012024-07-29
20886333227444ClosureFast Arterial NeedleAN-19GEAN-19GE2024-07-19

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