Identity
- Trade Name
- Res-Q-Vac FDA UDI
- Generic Name
- Emergency airway clearance suction system, manual FDA UDI
- Device Name
- REPL FSP RGD/SFT 10/14FR 14 ST FDA UDI
- Model / Reference
- R1F1B104S FDA UDI
- Description
- REPL FSP RGD/SFT 10/14FR 14 ST FDA UDI
Identifiers
- Catalog Number
- R1F1B104S FDA UDI
- Primary DI / UDI-DI
- 00659443002401 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
Res-Q-Vac by Repro Med Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Repro Med Systems, Inc.
Sources (1)
- FDA UDI fdeb37ae-70eb-4d04-bbf7-3741b69f8191 36 fields · synced Jun 8, 2026