Reservoir

FDA UDI

Class II (US FDA UDI)

by Medtronic Powered Surgical Solutions

Identity

Trade Name: Reservoir FDA UDI
Generic Name: Cranial port/reservoir FDA UDI
Device Name: RES 22101 A NEO FLAT DOME W/ 3.0CM VCATH FDA UDI
Model / Reference: 22101 A FDA UDI
Description: RES 22101 A NEO FLAT DOME W/ 3.0CM VCATH FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000980856 FDA UDI
510(k) Number: K874498 FDA UDI
FDA Product Code: LKG FDA UDI
GMDN Term: Cranial port/reservoir 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

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Cranial port/reservoir

Reservoir by Medtronic Powered Surgical Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Cranial port/reservoir.

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AESCULAP — AESCULAP, INC. · Class II
CODMAN® HOLTER® RICKHAM® — Integra LifeSciences Production Corporation · Class II
CODMAN® HOLTER® RICKHAM® — Integra LifeSciences Production Corporation · Class II

Cleared under the same submission

K874498 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 Powered Surgical Solutions

Sources (1)

FDA UDI d437798e-ced8-4237-aa2d-85d231b378a6 35 fields · synced Jun 9, 2026