Identity
- Trade Name
- Mizzy Comfort Cushion FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Device Name
- Stac Pac Analgegia Mask Cushion/Backplate Child (3) FDA UDI
- Model / Reference
- 6070165 FDA UDI
- Description
- Stac Pac Analgegia Mask Cushion/Backplate Child (3) FDA UDI
Identifiers
- Catalog Number
- 6070165 FDA UDI
- Primary DI / UDI-DI
- H66860701651 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
- 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaesthesia face mask, single-use
Mizzy Comfort Cushion by Keystone Industries — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
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- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
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
- Keystone Industries
Sources (1)
- FDA UDI 15b0a545-cd59-41d4-8f03-73d0e350e1e2 35 fields · synced Jun 9, 2026