Identity
- Trade Name
- GENTEC® FDA UDI
- Generic Name
- Tracheal suction vacuum regulator FDA UDI
- Device Name
- 881VR series suction regulator is a dual purpose suction regulator with continuous suctioning mode and intermittent suctioning mode. It can be used to medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning (continuous) or gastrointestinal suction (intermittent) FDA UDI
- Model / Reference
- 881VR-300-00-T FDA UDI
- Description
- 881VR series suction regulator is a dual purpose suction regulator with continuous suctioning mode and intermittent suctioning mode. It can be used to medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning (continuous) or gastrointestinal suction (intermittent) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970966660119 FDA UDI
- FDA Product Code
- KDP FDA UDI
- GMDN Term
- Tracheal suction vacuum regulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tracheal suction vacuum regulator
Gentec® by Gentec(shanghai)corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheal suction vacuum regulator.
- GENTEC® — GENTEC(SHANGHAI)CORPORATION · Class II
- GENTEC® — GENTEC(SHANGHAI)CORPORATION · Class II
- GENTEC® — GENTEC(SHANGHAI)CORPORATION · Class II
- GENTEC® — GENTEC(SHANGHAI)CORPORATION · Class II
- GENTEC® — GENTEC(SHANGHAI)CORPORATION · Class II
- GENTEC® — GENTEC(SHANGHAI)CORPORATION · Class II
- GENTEC® — GENTEC(SHANGHAI)CORPORATION · Class II
- GENTEC® — GENTEC(SHANGHAI)CORPORATION · 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 |
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Manufacturer
- Manufacturer
- Gentec(shanghai)corporation
Sources (1)
- FDA UDI a4ce6997-e7c9-4c7f-8c3f-45b002e11f8e 33 fields · synced Jun 1, 2026