The O R Company - InsufflatOR Tubing Set
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- InsufflatOR Tubing Set EUDAMEDThe O R Company - InsufflatOR Tubing Set FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, single-use FDA UDI
- Device Name
- Insufflation Filter with Tubing Set EUDAMED
- Model / Reference
- PFITF-10 EUDAMEDFDA UDIAIF-400Z, AIF-403Z, AIF-430Z, AIF-4400, AIF-460Z, AIF-4700, AIF-500Z, AIF-530Z, AIF-540Z, AIF-560Z, AIF-600Z, AIF-630Z, AIF-640Z, AIF-660Z, AIF-670Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711605992053 EUDAMEDFDA UDI
- Basic UDI-DI
- 471160599AIF0143 EUDAMED
- FDA Product Code
- NKC FDA UDI
- EMDN Code
- R040199 VENTILATION FILTERS - OTHER EUDAMED
- GMDN Term
- Endoscopic insufflation tubing set, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 884.1730 FDA UDI
- Market of Registration
- France 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: Endoscopic insufflation tubing set, single-use
The O R Company - InsufflatOR Tubing Set by Advanced Medical Design Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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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
- Advanced Medical Design Co., Ltd.
Sources (2)
- FDA UDI 33a8984a-09b3-442c-a097-09101d4d4715 32 fields · synced Oct 5, 2026
- EUDAMED 64262412-277b-479c-8b34-771020efab26 61 fields · synced Oct 1, 2026