Identity
- Trade Name
- MICROTEK FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- ARMSTRONG MICROKEY, 1-EACH FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- ARMSTRONG MICROKEY, 1-EACH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00748426121106 FDA UDI
- 510(k) Number
- K950770 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary resuscitation mask, reusable
Microtek by Microtek Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary resuscitation mask, reusable.
- OP - First aid series — Yiwu Ori-Power Medtech Co., Ltd. · Class I
- Pocket Mask O2, SP Black Private Label — Laerdal Medical Corp. · Class I
- Adsafe™ — American Diagnostic Corporation · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Pocket Mask w/O2, SP (Black IE) — Laerdal Medical Corp. · Class II
- HEADSTAR — Headstar Medical Products Co., Ltd. · Class I
- Pocket Mask, HC White Private Label — Laerdal Medical Corp. · Class I
- Adsafe™ — American Diagnostic Corporation · Class I
Cleared under the same submission
K950770 also covers:
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek 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
- Microtek Medical LLC
Sources (1)
- FDA UDI 1ecd1030-a97c-46e1-b44f-d809faad307f 36 fields · synced Jun 8, 2026