← Back to catalogue

Respiratory Plate Cushion Kit

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
Respiratory Plate Cushion Kit FDA UDI
Generic Name
Vacuum-mould patient positioning system FDA UDI
Device Name
Respiratory Plate, wide (1), Respiratory Plate Cushions (3) and Pump with Gauge (1) FDA UDI
Model / Reference
BPL120 FDA UDI
Description
Respiratory Plate, wide (1), Respiratory Plate Cushions (3) and Pump with Gauge (1) FDA UDI

Identifiers

Catalog Number
BPL120 FDA UDI
Primary DI / UDI-DI
00841439110461 FDA UDI
510(k) Number
K080072 FDA UDI
K935300 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Vacuum-mould patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Vacuum-mould patient positioning system

Respiratory Plate Cushion Kit by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vacuum-mould patient positioning system.

Cleared under the same submission

K080072 also covers:

K935300 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtec LLC

Sources (1)

  • FDA UDI efdd6f06-0236-4f2d-9d51-40641e9670d4 36 fields · synced May 31, 2026