FDA.reportPublic FDA data

Y-Connector

Primary DI
14251783104192
Brand
Y-Connector
Company
Assamed GmbH - Medizinbedarf
Model
06016400
Device description
Y-Connector
Published
2023-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFSUnit, Oral Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFSUnit, Oral IrrigationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14251783104192PackageGS1100In Commercial Distribution
24251783104199PackageGS12000In Commercial Distribution
04251783104195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425178310419214251783104192
2425178310419924251783104199
04251783104195042517831041954251783104195

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, reusableA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49(0)682681155thomas.flamm@assamed.de

Regulatory Flags#

DUNS number
319354346
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251783104454Irrigation Tubing Set 3.8 mWH.41 blau2026-04-24
04251783104195Y-Connector060164002023-04-03
04251783104164Reusable Irrigation Tubing Set 2.2 m047194002023-03-31
04251783104171Reusable Irrigation Tubing Set for elcoMED SA 200/ SA200C 2.2 m049767002023-03-31
14251783104161Reusable Irrigation Tubing Set 2.2 m047194002023-03-31
14251783104178Reusable Irrigation Tubing Set for elcoMED SA 200/ SA200C 2.2 m049767002023-03-31
04251783104133Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C043663002023-03-30
14251783104130Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C043663002023-03-30
04251783104010Irrigation Tubing with Luer-Lock (disposable) 2.2m009293002023-03-29
04251783104041Irrigation Tubing with Luer-Lock (disposable) 3.8 m009294002023-03-29
04251783104072Irrigation Tubing Set 2.2 m043636002023-03-29
04251783104102Irrigation Tubing Set 3.8 m043641002023-03-29
04251783104119Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m043651002023-03-29
04251783104126Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 2.2 m043653002023-03-29
04251783104188Suction Tubing Set 2 m053545002023-03-29
14251783104017Irrigation Tubing with Luer-Lock (disposable) 2.2m009293002023-03-29
14251783104048Irrigation Tubing with Luer-Lock (disposable) 3.8 m009294002023-03-29
14251783104079Irrigation Tubing Set 2.2 m043636002023-03-29
14251783104109Irrigation Tubing Set 3.8 m043641002023-03-29
14251783104116Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m043651002023-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073950346764Waterpik Cordless Pulse 3100 Water FlosserWATER PIK, INC.EFS2026-07-08
00073950341295Waterpik Cordless Pearl Water FlosserWATER PIK, INC.EFS2026-06-09
00073950345927Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-06-09
05060640673700OrdoORDOCLUB LTDEFS2026-05-29
00073950345897Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346122Waterpik Cordless Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346788Waterpik Cordless Pulse 3100 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950347167Waterpik Cordless 1200 Water FlosserWATER PIK, INC.EFS2026-05-26
08809260475687Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
08809260475694Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
00056310343412WaterPik Cordless Plus 5000 Water FlosserWATER PIK, INC.EFS2026-04-09
08052141311806Irrigation LineOMNIA SRLEFS2026-03-27
08052141312025Irrigation LineOMNIA SRLEFS2026-03-27
08052141312780Irrigation LineOMNIA SRLEFS2026-03-27
08052141312865Irrigation LineOMNIA SRLEFS2026-03-27
08052141312940Irrigation LineOMNIA SRLEFS2026-03-27
08052141313602Irrigation LineOMNIA SRLEFS2026-03-27
00073950255554Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
00073950338226Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
10073950255551Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
10073950338223Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
00197344199764MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
10197344199761MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
00197344199771MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
10197344199778MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
00050428005408CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005415CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005422CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
05060640672406OrdoORDOCLUB LTDEFS2026-02-06
00073950338189Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-02-03