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Vital Signs

FDA UDI

Class I (US FDA UDI)

by Renu Medical, Inc

Identity

Trade Name
Vital Signs FDA UDI
Generic Name
Intravenous pressure infusor, manual, single-use FDA UDI
Device Name
Vital Signs Pressure Infusor Bag 500cc FDA UDI
Model / Reference
RM-IN800012 FDA UDI
Description
Vital Signs Pressure Infusor Bag 500cc FDA UDI

Identifiers

Primary DI / UDI-DI
00816317022372 FDA UDI
FDA Product Code
KZD FDA UDI
GMDN Term
Intravenous pressure infusor, manual, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5420 FDA UDI
Commercial Distribution
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

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intravenous pressure infusor, manual, single-use

Vital Signs by Renu Medical, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous pressure infusor, manual, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Renu Medical, Inc

Sources (1)

  • FDA UDI 71626a80-ff0e-4c56-b11f-4df0ab417afe 33 fields · synced Jun 1, 2026