Tubing, with filter, sterile, for insuflation
FDA UDIEUDAMEDClass I (US FDA UDI)
by Promepla
Identity
- Trade Name
- Tubing, with filter, sterile, for insuflation FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- General Surgery Tubing Sets EUDAMED
- Model / Reference
- WA95005A EUDAMEDFDA UDI
Identifiers
- Catalog Number
- ONG04199ST119 FDA UDI
- Primary DI / UDI-DI
- 03700512905080 EUDAMEDFDA UDI
- Basic UDI-DI
- 037005129GSU-IEXH EUDAMED
- FDA Product Code
- NKC FDA UDI
- EMDN Code
- Z12029008 GAS INFLATORS EUDAMED
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 884.1730 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Surgical irrigation/aspiration tubing set
Tubing, with filter, sterile, for insuflation by Promepla — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration tubing set.
- LAMIS Tubing — Mentor Texas LP · Class I
- Aspiration Tubing — BLACK & BLACK SURGICAL, INC. · Class II
- MB ULTRA-LIMP TUBING — The Wells Johnson Company · Class II
- INFILTRATION TUBING — BLACK & BLACK SURGICAL, INC. · Class II
- Autofuse Tubing — Mentor Texas LP · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- LAMIS "Y" Tubing — Mentor Texas LP · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Promepla
Sources (2)
- FDA UDI f98403ba-1eba-495b-901f-0a41df03c1e2 33 fields · synced Aug 3, 2026
- EUDAMED ed28c7fc-97b8-4d0d-9b0f-bdbe7e5350b3 61 fields · synced Aug 3, 2026