FDA.reportPublic FDA data

Irrigation Syringe Attachment

Primary DI
00861361000234
Brand
Irrigation Syringe Attachment
Company
Biorep Technologies, Inc.
Model
1.0
Catalog number
ISA-001
Device description
The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings
Published
2025-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYZSyringe, Irrigating (Non Dental)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861361000241PackageGS15In Commercial Distribution
00861361000234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861361000241008613610002418613610002410861361000241
00861361000234008613610002348613610002340861361000234

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
3053304449customerservice@biorep.com

Regulatory Flags#

DUNS number
073724333
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858733006239DeTACH - Detachable Aortic Cross Clamp Head - Large1.0MI-XCHL-8512024-04-23
00858733006253DeTACH - Detachable Aortic Cross Clamp Head - Small1.0MI-XCHS-5512024-04-22
00858733006345DeTACH - Detachable Aortic Cross Clamp Head - Medium1.0MI-XCHM-6512024-04-23
00858733006284DeTACH Aortic Cross Clamp Delivery Device1.0MI-XCDD-0012024-04-23
00858733006291DeTACH Aortic Cross Clamp Quick Release Device1.0MI-XCQR-0012024-04-23
00861361000241Irrigation Syringe Attachment1.0ISA-0012025-02-14
00858733006000JOSEPH LAMELAS Knot Pusher8.0MI-KP-0012024-04-23
00858733006017JOSEPH LAMELAS Atrial Lift System10.0MI-ALS-0012024-04-23
00858733006024MI CUFF - Aortic Root Exposure Device4.0MI-CUFF-0012024-04-23
00858733006031COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle7.0MI-COTIE-0012024-04-23
00858733006048SUTURE BELT - Circumferential Suture Organizer9.0MI-ISBA-0012024-04-23
10858733006007JOSEPH LAMELAS Knot Pusher8.0MI-KP-0012024-04-23
10858733006014JOSEPH LAMELAS Atrial Lift System10.0MI-ALS-0012024-04-23
10858733006021MI CUFF - Aortic Root Exposure Device4.0MI-CUFF-0012024-04-23
10858733006038COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle7.0MI-COTIE-0012024-04-23
10858733006045SUTURE BELT - Circumferential Suture Organizer9.0MI-ISBA-0012024-04-23
00858733006062Joseph Lamelas Intercostal Retractor System Rack5.0MI-IRS-R-0012024-04-23
00858733006086MI Intercostal Retractor System (IRS) 222 Small Blade Set3.0MI-IRS-SB-P012024-04-23
00858733006093MI Intercostal Retractor System (IRS) 222 Medium Blade Set3.0MI-IRS-MB-P012024-04-23
00858733006109MI Intercostal Retractor System (IRS) 222 Large Blade Set3.0MI-IRS-LB-P012024-04-23

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Primary DI, Brand, Company table
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10192253068856MonojectCardinal Health 200, LLCKYZ2026-01-29
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00661392055155LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
10198956204768CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-10
10198956194649CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-08
10198956181540CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-08-14
10704411006152AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
10704411007074AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
10704411007098AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
00661392002258LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002265LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002845LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002852LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002920LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16