FDA.reportPublic FDA data

Reusable Irrigation Tubing Set 2.2 m

Primary DI
14251783104161
Brand
Reusable Irrigation Tubing Set 2.2 m
Company
Assamed GmbH - Medizinbedarf
Model
04719400
Device description
Reusable Irrigation Tubing Set 2.2 m
Published
2023-03-31
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
14251783104161PackageGS11In Commercial Distribution
24251783104168PackageGS120In Commercial Distribution
04251783104164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425178310416114251783104161
2425178310416824251783104168
04251783104164042517831041644251783104164

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.2Meter

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
14251783104192Y-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
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

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