FDA.reportPublic FDA data

Aspiration and Flush Assembly

Primary DI
00817640020202
Brand
Aspiration and Flush Assembly
Company
URESIL, LLC
Model
DFA-LL
Catalog number
DFA-LL
Device description
ASPIRATION FLUSH ADAPTER – DOUBLE CLAMP
Published
2022-05-19
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
GBOCatheter, Nephrostomy, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBOCatheter, Nephrostomy, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817640020209PackageGS15In Commercial Distribution
20817640020206PackageGS110In Commercial Distribution
H862DFALL0PreviousHIBCC0
00817640020202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081764002020910817640020209
2081764002020620817640020206
00817640020202008176400202028176400202020817640020202

GMDN Terms#

Term, Definition table
TermDefinition
Luer/Luer linear connector, single-useA small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-538-7374sales@uresil.com

Regulatory Flags#

DUNS number
192559557
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H862TC600L0Gravity Drainage BagTC600LTC600L2017-09-11
H862TFDR0Tru-Fix Catheter Fixation KitTFD-RTFD-R2016-08-31
H862TFK060Tru-Fix Catheter Fixation KitTFK-06TFK-062016-08-31
H862TFK080Tru-Fix Catheter Fixation KitTFK-08TFK-082016-08-31
H862TFK100Tru-Fix Catheter Fixation KitTFK-10TFK-102016-08-31
H862TFK120Tru-Fix Catheter Fixation KitTFK-12TFK-122016-08-31
H862TFK140Tru-Fix Catheter Fixation KitTFK-14TFK-142016-08-31
H862TFK160Tru-Fix Catheter Fixation KitTFK-16TFK-162016-08-31
00817640020639Tru-Fix Catheter Fixation KitTFD-RTFD-R2022-05-12
00817640020646Tru-Fix Catheter Fixation KitTFK-06TFK-062022-05-12
00817640020653Tru-Fix Catheter Fixation KitTFK-08TFK-082022-05-12
00817640020660Tru-Fix Catheter Fixation KitTFK-10TFK-102022-05-12
00817640020677Tru-Fix Catheter Fixation KitTFK-12TFK-122022-05-12
00817640020684Tru-Fix Catheter Fixation KitTFK-14TFK-142022-05-12
00817640020691Tru-Fix Catheter Fixation KitTFK-16TFK-162022-05-12
H862DFALL0Aspiration and Flush AssemblyDFA-LLDFA-LL2016-08-29
H862TV11100Thora-Vent Thoracic VentTV11-10TV11-102016-09-07
H862TV11130Thora-Vent Thoracic VentTV11-13TV11-132016-09-07
H862TV13100Thora-Vent Thoracic VentTV13-10TV13-102016-09-07
H862TV13130Thora-Vent Thoracic VentTV13-13TV13-132016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15051684011587Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011594Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011600Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011617Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011624Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011631Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011648Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011655Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011662Total AbscessionAngiodynamics, Inc.GBO2024-10-30
00812261011806allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012308allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012315allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261019222allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012292allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-08
00812261012285allDrainALLWIN MEDICAL DEVICES, INC.GBO2023-07-28
00817640020103Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020110Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020097GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-29
00817640020219GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-29
00817640020226GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-29
00817640020035GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020042GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020066GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020073GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020080GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020059GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-26
H862MPL2T1230H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-10
H862MPLT21430H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-10
H862GPJT0620H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPJT0825H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09