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SVR System without Patch

FDA UDI

Class II (US FDA UDI)

by Kdl Medical, Inc.

Identity

Trade Name
SVR System without Patch FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Device Name
SVR System with 80cc Mannequin™ without Patch FDA UDI
Model / Reference
SVC-0080S FDA UDI
Description
SVR System with 80cc Mannequin™ without Patch FDA UDI

Identifiers

Primary DI / UDI-DI
00899054002166 FDA UDI
510(k) Number
K020233 FDA UDI
FDA Product Code
DXZ FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3470 FDA UDI
Commercial Distribution
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

Category: Catheter/overtube balloon inflator, single-use

SVR System without Patch by Kdl Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

Cleared under the same submission

K020233 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kdl Medical, Inc.

Sources (1)

  • FDA UDI eaf24597-5061-4f52-9540-982c616419d4 34 fields · synced May 30, 2026