← Back to catalogue
Classic
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref HUU19018GT0SSNGKModel Classic : tube models consist of different lengths and diameters, different rib Colour, flexibility of cuff and tube
Identity
- Trade Name
- Classic 19 US EUDAMEDClassic FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Non-heated respiratory tubes EUDAMED
- Model / Reference
- Classic : tube models consist of different lengths and diameters, different rib Colour, flexibility of cuff and tube EUDAMEDHUU19018GT0SSNGK EUDAMEDClassic 19 US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05404013001484 EUDAMEDFDA UDI
- Basic UDI-DI
- 54040130000000000000067 EUDAMED
- FDA Product Code
- BZO FDA UDI
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5975 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ventilator breathing circuit, reusable
Classic by Plastiflex Group NV — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator breathing circuit, reusable.
- KC 042-B - 22mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 004-GG - 22mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 042-3 22mm ID Ventilator Tubing with Integral Cuffs — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 048-N - 10mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 036-N - 10mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 018-P - 15mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- RESMED — RESMED PTY LTD · Class I
- Vivo Series — Breas Medical AB · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Plastiflex Group NV
Sources (2)
- FDA UDI 4b5005c2-f208-4d9f-93df-8a08ac4a36af 32 fields · synced Jun 18, 2026
- EUDAMED e402b091-4225-47c2-80c9-1a45c1a8c7b3 61 fields · synced Jun 18, 2026