Identity
- Trade Name
- BREATHING SYSTEM TUBE SUPPORT FOR INTERSURGICAL 10MM AND 15MM TUBING FDA UDI
- Generic Name
- Breathing circuit tube holder FDA UDI
- Device Name
- Tube Management Devices EUDAMEDBREATHING SYSTEM TUBE SUPPORT FOR INTERSURGICAL 10MM AND 15MM TUBING FDA UDI
- Model / Reference
- 5905000 EUDAMEDFDA UDI
- Description
- BREATHING SYSTEM TUBE SUPPORT FOR INTERSURGICAL 10MM AND 15MM TUBING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267019106 EUDAMEDFDA UDI
- Basic UDI-DI
- 05030267TMDP8 EUDAMED
- FDA Product Code
- JAY FDA UDI
- EMDN Code
- R028099 RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Breathing circuit tube holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5280 FDA UDI
- Market of Registration
- Sweden 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
Yes
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
MR Unsafe FDA UDI
Tube Management Devices by Intersurgical Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 05030267TMDP8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Intersurgical Ltd
- EUDAMED SRN
- GB-MF-000004798
- Authorised Representative
- UAB Intersurgical LT-AR-000003907
Sources (2)
- EUDAMED 9b66ae5f-9615-4397-bda9-1adece55567c 61 fields · synced Jun 19, 2026
- FDA UDI 280d3741-fced-4e44-844b-e49d6d6baec5 34 fields · synced May 29, 2026