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AMSafe® Standardbore Extension Set

FDA UDI

Class II (US FDA UDI)

by Amsino International, Inc.

Identity

Trade Name
AMSafe® Standardbore Extension Set FDA UDI
Generic Name
Basic intravenous administration set, noninvasive FDA UDI
Device Name
AMSafe® Standardbore Extension Set 100 inch long (254cm) CAUTION: Avoid freezing and excessive heat. FDA UDI
Model / Reference
1 FDA UDI
Description
AMSafe® Standardbore Extension Set 100 inch long (254cm) CAUTION: Avoid freezing and excessive heat. FDA UDI

Identifiers

Catalog Number
IVE2500 FDA UDI
Primary DI / UDI-DI
10704411012177 FDA UDI
510(k) Number
K093773 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Basic intravenous administration set, noninvasive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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: Basic intravenous administration set, noninvasive

AMSafe® Standardbore Extension Set by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic intravenous administration set, noninvasive.

Cleared under the same submission

K093773 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amsino International, Inc.

Sources (1)

  • FDA UDI 7c176865-1964-484b-9470-1e73f3911af0 35 fields · synced May 29, 2026