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Patient Circuit - Pediatric, 1.8m, 1 pcs, one way
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Patient Circuit - Pediatric, 1.8m, 1 pcs, one way FDA UDI
- Generic Name
- Inspiratory/expiratory limb respiratory tubing, single-use FDA UDI
- Model / Reference
- VWSP-550F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017096773 FDA UDI
- 510(k) Number
- K202970 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Inspiratory/expiratory limb respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Inspiratory/expiratory limb respiratory tubing, single-use
Patient Circuit - Pediatric, 1.8m, 1 pcs, one way by Inovytec Medical Solutions Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K202970 also covers:
- Inlet Filter - Regular — INOVYTEC MEDICAL SOLUTIONS LTD
- Patient Circuit - Adult, 2.4m, 1 pcs — INOVYTEC MEDICAL SOLUTIONS LTD
- Patient Circuit - Pediatric, 2.4m, 1 pcs — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow MRI — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow MRI Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow MRI Robust Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Robust — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Robust Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Robust Ventilator MRI Compatible — INOVYTEC MEDICAL SOLUTIONS LTD
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inovytec Medical Solutions Ltd
Sources (2)
- FDA UDI e1cd2def-9a9e-41aa-8e5f-5a0e651b7cff 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026