Identity
- Trade Name
- ShurClear FDA UDI
- Generic Name
- Positive pressure airway secretion-clearing device FDA UDI
- Model / Reference
- IS-37002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043370025 FDA UDI
- 510(k) Number
- K121587 FDA UDI
- FDA Product Code
- BYI FDA UDI
- GMDN Term
- Positive pressure airway secretion-clearing device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5665 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Positive pressure airway secretion-clearing device
ShurClear by Mercury Enterprises, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Positive pressure airway secretion-clearing device.
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class II
- Comfort Cough — Seoil Pacific Corp. · Class II
- CoughAssist — Respironics, Inc. · Class II
- CoughAssist — Respironics, Inc. · Class II
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class I
- Portex — ICU MEDICAL, INC. · Class II
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class II
- CoughAssist — Respironics, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mercury Enterprises, Inc.
Sources (1)
- FDA UDI 9f7d4e4d-4d39-4468-9b07-1f052d320bef 34 fields · synced May 30, 2026