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Resp-O2 Comfort-Foam Trach Tube Holder, Anti-Disconnect, 1 PC, Neonatal & Infant
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Resp-O2 Comfort-Foam Trach Tube Holder,Anti-Disconnect,1 PC,Neonatal & Infant FDA UDI
- Generic Name
- Tracheostomy tube neck holder, single-use FDA UDI
- Device Name
- Small, Anti-disconnect Neonatal and Infant, Neck 7"-9"/18-23 cm FDA UDI
- Model / Reference
- 35024 FDA UDI
- Description
- Small, Anti-disconnect Neonatal and Infant, Neck 7"-9"/18-23 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117319226 FDA UDI
- FDA Product Code
- CBH FDA UDI
- GMDN Term
- Tracheostomy tube neck holder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5770 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tracheostomy tube neck holder, single-use
Resp-O2 Comfort-Foam Trach Tube Holder, Anti-Disconnect, 1 PC, Neonatal & Infant by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Tracheostomy tube neck holder, single-use.
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- Marpac Inc — Marpac, Inc. · Class I
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 108f8613-4d06-4a21-90e7-198d71bf14c0 33 fields · synced Jun 1, 2026