← Back to catalogue

Res-Q-Vac

FDA UDI

Class I (US FDA UDI)

by Repro Med Systems, Inc.

Identity

Trade Name
Res-Q-Vac FDA UDI
Generic Name
Emergency airway clearance suction system, manual FDA UDI
Device Name
RES-Q-VAC BULK PACK MILITARY FDA UDI
Model / Reference
P0000000BM FDA UDI
Description
RES-Q-VAC BULK PACK MILITARY FDA UDI

Identifiers

Catalog Number
P0000000BM FDA UDI
Primary DI / UDI-DI
00659443002760 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
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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Res-Q-Vac by Repro Med Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K894299 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Repro Med Systems, Inc.

Sources (1)

  • FDA UDI dfc7af11-5e7e-419c-9068-1bc5548b4ad3 37 fields · synced Jun 6, 2026