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Dosi-Fuser

FDA UDI

Class II (US FDA UDI)

by Leventon Sau

Identity

Trade Name
DOSI-FUSER FDA UDI
Generic Name
Elastomeric infusion pump system FDA UDI
Device Name
Elastomeric Infusion Pump FDA UDI
Model / Reference
L25915-150D2-USAXL FDA UDI
Description
Elastomeric Infusion Pump FDA UDI

Identifiers

Primary DI / UDI-DI
08436020768255 FDA UDI
510(k) Number
K040752 FDA UDI
FDA Product Code
MEB FDA UDI
GMDN Term
Elastomeric infusion pump system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 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

Dimensions & Sizes

Size
Total Volume — 150 Milliliter FDA UDI

Dosi-Fuser by Leventon Sau — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K040752 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Leventon Sau

Sources (1)

  • FDA UDI 309ccf8f-4cc5-4b96-b292-f29adbade076 37 fields · synced May 30, 2026