Vital Signs™

FDA UDI

Class II (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name: Vital Signs™ FDA UDI
Generic Name: Pulmonary resuscitator, manual, single-use FDA UDI
Device Name: Vital Signs™ flow-inflating tail-end valve transport circuit FDA UDI
Model / Reference: 5102RCV1 FDA UDI
Description: Vital Signs™ flow-inflating tail-end valve transport circuit FDA UDI

Identifiers

Catalog Number: 5102RCV1 FDA UDI
Primary DI / UDI-DI: 10889483585054 FDA UDI
510(k) Number: K812273 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Pulmonary resuscitator, manual, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulmonary resuscitator, manual, single-use

Vital Signs™ by Airlife, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary resuscitator, manual, single-use.

Ventlab — Ventlab Corp. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
VT Sure — Pulmodyne Inc. · Class II
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
Ventlab — Ventlab Corp. · Class I
Ventlab — Ventlab Corp. · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II

Cleared under the same submission

K812273 also covers:

Vital Signs™ — Airlife, Inc.
Vital Signs™ — Airlife, 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 II	Pending data

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Manufacturer

Manufacturer: Airlife, Inc.

Sources (1)

FDA UDI f9aae821-a168-4a68-9b0c-e083ee577f22 36 fields · synced May 29, 2026