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Epimed

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc

Identity

Trade Name
Epimed FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
Extension Set, 12" FDA UDI
Model / Reference
1911-512 FDA UDI
Description
Extension Set, 12" FDA UDI

Identifiers

Catalog Number
1911-512 FDA UDI
Primary DI / UDI-DI
00818788021595 FDA UDI
510(k) Number
K020926 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Intravenous administration tubing extension set 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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 12 Inch FDA UDI

Category: Intravenous administration tubing extension set

Epimed by Epimed International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous administration tubing extension set.

Cleared under the same submission

K020926 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epimed International, Inc

Sources (1)

  • FDA UDI 248917e9-c092-484d-8c7a-aa8fc555aff4 38 fields · synced Jun 8, 2026