Ventlab

FDA UDI

Class II (US FDA UDI)

by Ventlab Corp.

Identity

Trade Name: Ventlab FDA UDI
Generic Name: Pulmonary resuscitator, manual, single-use FDA UDI
Device Name: T-Piece Resuscitator with 7ft O2 tubing, Neonate Soft Seal Round mask & Pop-off Override FDA UDI
Model / Reference: ST714 FDA UDI
Description: T-Piece Resuscitator with 7ft O2 tubing, Neonate Soft Seal Round mask & Pop-off Override FDA UDI

Identifiers

Catalog Number: ST714 FDA UDI
Primary DI / UDI-DI: 10889483231777 FDA UDI
510(k) Number: K173373 FDA UDI
FDA Product Code: BTL FDA UDI
GMDN Term: Pulmonary resuscitator, manual, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5925 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Pulmonary resuscitator, manual, single-use

Ventlab by Ventlab Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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VT Sure — Pulmodyne Inc. · Class II
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
Rescu-7 Reservoir bag, 600ml — GaleMed Corporation · Class IIa
AirLife™ — Airlife, Inc. · Class II
Portex — ICU MEDICAL, INC. · Class II

Cleared under the same submission

K173373 also covers:

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: Ventlab Corp.

Sources (1)

FDA UDI f73951f2-308b-4ee6-977a-fd8bac79709a 36 fields · synced May 30, 2026