Identity
- Trade Name
- Isolaer Aerosol Isolation Barrier FDA UDI
- Generic Name
- Patient examination/treatment drape, single-use FDA UDI
- Device Name
- The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that minimizes exposure of aerosols during ENT procedures. FDA UDI
- Model / Reference
- IB-1000 FDA UDI
- Description
- The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that minimizes exposure of aerosols during ENT procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005664009 FDA UDI
- FDA Product Code
- ERY FDA UDI
- GMDN Term
- Patient examination/treatment drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Isolaer Aerosol Isolation Barrier by Inquis Medical, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Inquis Medical, Inc.
Sources (1)
- FDA UDI f05fb89b-b8a5-4a3a-9d91-e3dff05620d8 35 fields · synced May 30, 2026