Identity
- Trade Name
- Ventlab FDA UDI
- Generic Name
- Exhaled-gas oesophageal intubation detector FDA UDI
- Device Name
- Cannula, CO2 Sampling, Adult, 7' O2, 7' CO2 FDA UDI
- Model / Reference
- HCSA4568 FDA UDI
- Description
- Cannula, CO2 Sampling, Adult, 7' O2, 7' CO2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10889483095157 FDA UDI
- 510(k) Number
- K063813 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Exhaled-gas oesophageal intubation detector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 22 Millimeter FDA UDILength — 7 Feet FDA UDI
Category: Exhaled-gas oesophageal intubation detector
Ventlab by Ventlab Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K063813 also covers:
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ventlab Corp.
Sources (1)
- FDA UDI 47e1faa6-072d-40a8-9119-58a356decc8b 37 fields · synced May 30, 2026