Terumo

FDA UDI

Class II (US FDA UDI)

by Terumo (Philippines) Corporation

Identity

Trade Name: TERUMO FDA UDI
Generic Name: Metered-delivery hypodermic syringe FDA UDI
Device Name: TERUMO Syringe without Needle FDA UDI
Model / Reference: SS-30ES FDA UDI
Description: TERUMO Syringe without Needle FDA UDI

Identifiers

Primary DI / UDI-DI: 34806017511433 FDA UDI
510(k) Number: K063613 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Metered-delivery hypodermic syringe FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Dimensions & Sizes

Size: Total Volume — 30 Milliliter FDA UDI

Category: Metered-delivery hypodermic syringe

Terumo by Terumo (Philippines) Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Metered-delivery hypodermic syringe.

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Monoject — Cardinalhealth · Class II
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Monoject — Cardinalhealth · Class II
HSW NORM-JECT® — Henke-Sass, Wolf GmbH · Class II

Cleared under the same submission

K063613 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: Terumo (Philippines) Corporation

Sources (1)

FDA UDI bb80a14a-0c79-41a2-9f08-98f10045d025 37 fields · synced May 31, 2026