Identity
- Trade Name
- Res-Q-Vac FDA UDI
- Generic Name
- Emergency airway clearance suction system, manual FDA UDI
- Device Name
- REPL FSP All Catheters ST FDA UDI
- Model / Reference
- R1F001AFS FDA UDI
- Description
- REPL FSP All Catheters ST FDA UDI
Identifiers
- Catalog Number
- R1F001AFS FDA UDI
- Primary DI / UDI-DI
- 00659443002364 FDA UDI
- 510(k) Number
- K894299 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Emergency airway clearance suction system, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6810 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Emergency airway clearance suction system, manual
A comprehensive medical device directory listing for the Res-Q-Vac emergency airway clearance suction system. This portable assembly of devices is designed to manually aspirate unwanted materials from the airway, typically during patient transport or an emergency situation.
Similar devices
Also classified as Emergency airway clearance suction system, manual.
- Aspirator — Vitalograph Ireland, Ltd. · Class II
- NAR TACTICAL SUCTION DEVICE — NORTH AMERICAN RESCUE, LLC. · Class I
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class I
- Res-Q-Vac — REPRO MED SYSTEMS, INC. · Class I
- Res-Q-Vac — REPRO MED SYSTEMS, INC. · Class I
- Res-Q-Vac — REPRO MED SYSTEMS, INC. · Class I
- Res-Q-Vac — REPRO MED SYSTEMS, INC. · Class I
- Res-Q-Vac — REPRO MED SYSTEMS, INC. · Class I
Cleared under the same submission
K894299 also covers:
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
- Res-Q-Vac — REPRO MED SYSTEMS, INC.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Repro Med Systems, Inc.
Sources (1)
- FDA UDI 05da00f7-2502-4c40-947e-271d79013cc4 36 fields · synced Jun 29, 2026