Identity
- Trade Name
- AeroClear FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
- Device Name
- The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. Inserted on this tubing is a yellow foam seal and a black positioning ring that can both slide along the tubing. A spare larger foam seal and a male connector are also supplied. When surgery is performed in one nasal cavity, the AeroClear is placed in the contralateral cavity and connected to facility suction. FDA UDI
- Model / Reference
- 9770013 FDA UDI
- Description
- The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. Inserted on this tubing is a yellow foam seal and a black positioning ring that can both slide along the tubing. A spare larger foam seal and a male connector are also supplied. When surgery is performed in one nasal cavity, the AeroClear is placed in the contralateral cavity and connected to facility suction. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858439001774 FDA UDI
- FDA Product Code
- JOL FDA UDI
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
AeroClear by Hemostasis, LLC — 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
- Hemostasis, LLC
Sources (1)
- FDA UDI 8b5b5875-3ea0-416a-ba16-e74acde5e25d 36 fields · synced Jun 1, 2026