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AirLife™

FDA UDI

Class II (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name
AirLife™ FDA UDI
Generic Name
Intravenous/irrigation solution storage container, single-use FDA UDI
Model / Reference
5251 FDA UDI

Identifiers

Catalog Number
5251 FDA UDI
Primary DI / UDI-DI
10889483585702 FDA UDI
510(k) Number
K090915 FDA UDI
FDA Product Code
BTT FDA UDI
GMDN Term
Intravenous/irrigation solution storage container, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5450 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intravenous/irrigation solution storage container, single-use

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

Similar devices

Also classified as Intravenous/irrigation solution storage container, single-use.

Cleared under the same submission

K090915 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Airlife, Inc.

Sources (1)

  • FDA UDI bba06c26-acc0-4f93-85ed-6b6a21b76c92 35 fields · synced May 30, 2026