FDA.reportPublic FDA data

Irrigation Tubing Set 3.8 m

Primary DI
04251783104454
Brand
Irrigation Tubing Set 3.8 m
Company
Assamed GmbH - Medizinbedarf
Model
WH.41 blau
Device description
Irrigation Tubing Set 3.8 m
Published
2026-04-24
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
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251783104454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251783104454042517831044544251783104454

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
Length3.8Meter

Contacts#

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

Regulatory Flags#

DUNS number
319354346
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

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