FDA.reportPublic FDA data

20G 8CM Stiletto Extended Dwell Catheter

Primary DI
10850042365059
Brand
20G 8CM Stiletto Extended Dwell Catheter
Company
Avia Vascular, LLC
Model
PIP200000
Device description
The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration (
Published
2024-06-25
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNDMidline Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNDMidline CatheterGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210047000Stiletto Extended Dwell CatheterPiper Access, LLC2021-08-27PND

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850042365059PackageGS110In Commercial Distribution
20850042365056PackageGS12In Commercial Distribution
00850051842001PreviousGS10
00850042365052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004236505910850042365059
2085004236505620850042365056
00850051842001008500518420018500518420010850051842001
00850042365052008500423650528500423650520850042365052

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length80Millimeter
Outer Diameter1.1Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(801) 824-5375info@avia-vascular.com

Regulatory Flags#

DUNS number
106772781
Device count
1
DM exempt
true
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0085004236505220G 8CM Stiletto Extended Dwell CatheterPIP2000002024-06-25
0085004236500720G Open-System Ally Blood Collection DeviceAV1000002022-10-24
0085004236501422G Open-System Ally Blood Collection DeviceAV1100002022-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
36927675517273SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517280SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517297SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517303SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517310SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675519857SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675519864SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675520730SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675520747SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675520754SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
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00801741213243Provena MidlineBard Access Systems, Inc.PND2020-05-18