Identity
- Trade Name
- Custom Healthcare Systems Inc. FDA UDI
- Generic Name
- Tracheostomy kit, single-use FDA UDI
- Model / Reference
- D8-9425B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811870035012 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Tracheostomy kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Custom Healthcare Systems Inc. by Manus Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Manus Medical, LLC
Sources (1)
- FDA UDI 58698e59-7f59-4bd3-8e98-c415e28c295b 33 fields · synced May 30, 2026