Identity
- Trade Name
- SAFE SEDATE® FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Device Name
- Note: KS2-SSSMALLUNSC is new part number for KS2 SSSMALLUNSCE. Product did not change. FDA UDI
- Model / Reference
- KS2-SSSMALLUNSC FDA UDI
- Description
- Note: KS2-SSSMALLUNSC is new part number for KS2 SSSMALLUNSCE. Product did not change. FDA UDI
Identifiers
- Catalog Number
- KS2-SSSMALLUNSC FDA UDI
- Primary DI / UDI-DI
- 00612649205021 FDA UDI
- FDA Product Code
- BSJ FDA UDI
- GMDN Term
- Anaesthesia face mask, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5550 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Safe Sedate® by King Systems Corporation. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- King Systems Corporation.
Sources (1)
- FDA UDI 02179e3f-8938-4b5f-ad53-6fb46ab73cc1 37 fields · synced May 30, 2026