BluHale PRO™

FDA UDI

Class I (US FDA UDI)

by Mannkind Corporation

Identity

Trade Name: BluHale PRO™ FDA UDI
Generic Name: Air/gas pressure transducer FDA UDI
Model / Reference: PRO-MKC FDA UDI

Identifiers

Primary DI / UDI-DI: 00347918000037 FDA UDI
FDA Product Code: BYR FDA UDI
GMDN Term: Air/gas pressure transducer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.2875 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Air/gas pressure transducer

BluHale PRO™ by Mannkind Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air/gas pressure transducer.

Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
ATMOS Air-Charged Pressure Sensor — MEDKONSULT medical technology s.r.o. · Class II
MedPak — LIFEPORT, LLC. · Class II
Air-Charged Reusable Cable — Laborie Medical Technologies Canada ULC · Class II
MEDPAK — LIFEPORT, LLC. · Class I
ATMOS Air-Charged Pressure Sensor — MEDKONSULT medical technology s.r.o. · Class II
Air-Charged Reusable Cable — Laborie Medical Technologies Canada ULC · Class II
Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Mannkind Corporation

Sources (1)

FDA UDI ea5c37b9-f87d-43be-8ef5-cbf79c882023 32 fields · synced May 30, 2026