Delta®

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name: Delta® FDA UDI
Generic Name: Ventriculo-peritoneal/atrial shunt FDA UDI
Device Name: SHUNT 25131-5 INTL ONLY DELTA SM 1.5 FDA UDI
Model / Reference: 25131-5 FDA UDI
Description: SHUNT 25131-5 INTL ONLY DELTA SM 1.5 FDA UDI

Identifiers

Primary DI / UDI-DI: 00613994803719 FDA UDI
510(k) Number: K042465 FDA UDI
FDA Product Code: JXG FDA UDI
GMDN Term: Ventriculo-peritoneal/atrial shunt FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5550 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 90.0 Centimeter FDA UDI
Outer Diameter — 2.5 Millimeter FDA UDI

Category: Ventriculo-peritoneal/atrial shunt

Delta® by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K042465 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: Medtronic PS Medical

Sources (1)

FDA UDI 7c51b8ce-ba13-4684-b136-284af7f116bf 36 fields · synced May 31, 2026