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extriCARE

FDA UDI

Class II (US FDA UDI)

by Oakwell Distribution, Inc.

Identity

Trade Name
extriCARE FDA UDI
Generic Name
Multi-purpose low-vacuum suction system FDA UDI
Device Name
2400 100CC Canister FDA UDI
Model / Reference
EC2400-100C-E FDA UDI
Description
2400 100CC Canister FDA UDI

Identifiers

Primary DI / UDI-DI
00879766005495 FDA UDI
510(k) Number
K132252 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Multi-purpose low-vacuum suction system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-purpose low-vacuum suction system

extriCARE by Oakwell Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose low-vacuum suction system.

Cleared under the same submission

K132252 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oakwell Distribution, Inc.

Sources (1)

  • FDA UDI a3b50a30-f826-4e8c-87ea-127bf21cd44a 34 fields · synced Jun 6, 2026