FDA.reportPublic FDA data

20G 8CM Stiletto Extended Dwell Catheter

Primary DI
00850051842001
Brand
20G 8CM Stiletto Extended Dwell Catheter
Company
Slipstream Medical, 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
2024-02-05
Public version status
New
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
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
00850051842049PackageGS12In Commercial Distribution
10850051842008PackageGS110In Commercial Distribution
00850051842001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051842049008500518420498500518420490850051842049
1085005184200810850051842008
00850051842001008500518420018500518420010850051842001

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) 210-2452info@slipstreammedical.com

Regulatory Flags#

DUNS number
121638194
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
10801902213065ARROWTELEFLEX INCORPORATEDPND2024-08-01
10801902213089ARROWTELEFLEX INCORPORATEDPND2024-08-01
10801902218862ARROWTELEFLEX INCORPORATEDPND2024-01-29
10801902218855ARROWTELEFLEX INCORPORATEDPND2024-01-24
10801902216820ARROWTELEFLEX INCORPORATEDPND2023-09-13
10801902216837ARROWTELEFLEX INCORPORATEDPND2023-09-13
10801902201482ARROWTELEFLEX INCORPORATEDPND2022-10-13
10801902201499ARROWTELEFLEX INCORPORATEDPND2022-10-13
10801902201505ARROWTELEFLEX INCORPORATEDPND2022-10-13
10801902205466ARROWTELEFLEX INCORPORATEDPND2022-09-30
10801902205473ARROWTELEFLEX INCORPORATEDPND2022-09-30
10801902205480ARROWTELEFLEX INCORPORATEDPND2022-06-03
10801902205497ARROWTELEFLEX INCORPORATEDPND2022-06-03
10801902188400ARROWTELEFLEX INCORPORATEDPND2021-12-14
10801902188417ARROWTELEFLEX INCORPORATEDPND2021-12-14
10801902189353ARROWTELEFLEX INCORPORATEDPND2021-04-05
00801741215728Provena MidlineBard Access Systems, Inc.PND2020-10-23
00801741215674Provena MidlineBard Access Systems, Inc.PND2020-10-01
00801741213281Provena MidlineBard Access Systems, Inc.PND2020-07-20
00801741213243Provena MidlineBard Access Systems, Inc.PND2020-05-18