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Epimed

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc.

Identity

Trade Name
Epimed FDA UDI
Generic Name
Epidural anaesthesia set, non-medicated FDA UDI
Device Name
R.E.C.™ 19g x 33.25" FDA UDI
Model / Reference
155-1353 FDA UDI
Description
R.E.C.™ 19g x 33.25" FDA UDI

Identifiers

Catalog Number
155-1353 FDA UDI
Primary DI / UDI-DI
00818788021038 FDA UDI
510(k) Number
K954584 FDA UDI
FDA Product Code
BSO FDA UDI
GMDN Term
Epidural anaesthesia set, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5120 FDA UDI
Commercial Distribution
Not 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 — 33.25 Inch FDA UDI
Catheter Gauge — 3.2 French FDA UDI

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

Cleared under the same submission

K954584 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 a50bf698-ccb7-4750-8a68-d80633dba4ee 39 fields · synced Jun 4, 2026