FDA.reportPublic FDA data

Forté® Y- Adapter Seal

Primary DI
00607915118297
Brand
Forté® Y- Adapter Seal
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
B2101
Device description
Adapter Seal
Published
2016-09-24
Public version status
Update
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
EYIAdaptor, Ureteral Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYIAdaptor, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607915118294PackageGS15In Commercial Distribution
00607915118297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060791511829410607915118294
00607915118297006079151182976079151182970607915118297

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter flush valve, continuousA specialized, sterile, Y-piece device intended to be connected in an infusion line to an indwelling catheter and provide for the connection of a second infusion source. The second source usually serves to maintain a low keep vein open (KVO) flow in the catheter to prevent clotting. This device (the flush valve) may be equipped with a manually-operated mechanism to permit flushing of the line at a free-flow rate. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags#

DUNS number
187129135
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607915145313GelPOINT V-PathC2B112023-03-17
10607915145320GelPOINT V-PathC2B122023-03-17
10607915145337GelPOINT V-PathC2B152023-03-17
10607915145344GelPOINT V-PathC2C112023-03-17
10607915145368GelPOINT V-PathC2C152023-03-17
10607915146693GelPOINT V-PathC2B172023-03-17
00607915110123Epix Laparoscopic ScissorsCB0302016-09-24
00607915110130Epix Laparoscopic ScissorsCB0402016-09-24
00607915142087Alexis® Lighted Wound Protector-RetractorCL4022026-04-22
00607915148553Alexis® Lighted Wound Protector-RetractorCL3022026-04-22
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceC2R122026-04-22
00607915146498Suction Irrigation SystemC60012024-02-01
00607915146504Suction Irrigation SystemC60032024-02-01
00607915110147Epix Laparoscopic GrasperC41302016-08-30
00607915110154Epix Laparoscopic GrasperC41402016-08-30
00607915116866Direct Drive Reposable GraspersC41202016-08-30
00607915116873Direct Drive Reposable GraspersC41212016-08-30
00607915126773Inzii Retrieval SystemCD0042016-09-24
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915126964Epix ® Laparoscopic Dissector CY0102016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015241306uFloHUMAN HYDROLOGY DEVICES INCEYI2026-07-16
00860015241313uFloHUMAN HYDROLOGY DEVICES INCEYI2026-07-16
00085412478296BaxterBAXTER HEALTHCARE CORPORATIONEYI2026-05-29
00085412478302BaxterBAXTER HEALTHCARE CORPORATIONEYI2026-05-29
00661392010574LSL HEALTHCARELSL Industries, LLCEYI2025-10-30
00860001236002ADDTOAddtoEYI2020-07-15
00860001236026ADDTOAddtoEYI2020-07-15
10801741130479Bard® Ureteral Catheter AdapterC. R. Bard, Inc.EYI2017-12-11