FDA.reportPublic FDA data

Advanced Series Y-Connector

Primary DI
10851978007426
Brand
Advanced Series Y-Connector
Company
Pensar Medical, LLC
Model
8463540 0756
Device description
Advanced Series Y-Connector, 10 per case
Published
2022-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150960000WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC2016-12-01OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851978007426PrimaryGS10
00851978007429Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085197800742610851978007426
00851978007429008519780074298519780074290851978007429

GMDN Terms#

Term, Definition table
TermDefinition
Low-pressure tubing connector, single-use, non-sterileA non-sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a single-use device.

Regulatory Flags#

DUNS number
079262228
Device count
10
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851978007801Ultra Seal Preferred Strips (5/pouch)8463550 30282025-12-01
00851978007689MicroDoc NPWT System8463550 50042025-03-19
00851978007696MicroDoc NPWT System8463550 50012025-03-19
00851978007702MicroDoc NPWT System8463550 50022025-03-19
00851978007719MicroDoc NPWT System8463550 50062025-03-19
00851978007726MicroDoc NPWT System8463550 50032025-03-19
00851978007733MicroDoc NPWT System8463550 50072025-03-19
00851978007740MicroDoc NPWT System8463550 50112025-03-19
00851978007757MicroDoc NPWT System8463550 50142025-03-19
00851978007764MicroDoc NPWT System8463550 50122025-03-19
00851978007771MicroDoc NPWT System8463550 50162025-03-19
00851978007788MicroDoc NPWT System8463550 50132025-03-19
00851978007795MicroDoc NPWT System8463550 50172025-03-19
10851978007662WoundPro+ Collection Canister8463540 09412025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' Tubing8463540 09462025-03-18
00851978007665WoundPro+ Collection Canister8463540 09412025-03-18
00851978007672WoundPro+ 300cc Advanced Canister w/8' Tubing8463540 09462025-03-18
00851978007641MicroDoc NPWT System8463550 40172025-03-04
00851978007658MicroDoc NPWT System8463550 40072025-03-04
10851978007631WoundPro+ 300cc Advanced Canister w/5' Tubing8463540 09162025-01-14

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00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
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10851978007679WoundPro+ 300cc Advanced Canister w/8' TubingPensar Medical, LLCOMP2025-03-18
10851978007631WoundPro+ 300cc Advanced Canister w/5' TubingPensar Medical, LLCOMP2025-01-14
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