Respiratory Pump and Gauge

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name: Respiratory Pump and Gauge FDA UDI
Generic Name: Radiological whole-body positioner FDA UDI
Device Name: Respiratory Pump and Gauge FDA UDI
Model / Reference: BPL009 FDA UDI
Description: Respiratory Pump and Gauge FDA UDI

Identifiers

Catalog Number: BPL009 FDA UDI
Primary DI / UDI-DI: 00841439110454 FDA UDI
510(k) Number: K153026 FDA UDI
FDA Product Code: IYE FDA UDI
LNH FDA UDI
GMDN Term: Radiological whole-body positioner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 FDA UDI
892.1000 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Radiological whole-body positioner

Respiratory Pump and Gauge by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Radiological whole-body positioner.

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Cleared under the same submission

K153026 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: Medtec LLC

Sources (1)

FDA UDI 65349436-d490-45ff-a640-4eb405c15f01 36 fields · synced Jun 8, 2026