BleaseFocus

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name: BleaseFocus FDA UDI
Generic Name: Anaesthesia unit, mobile FDA UDI
Device Name: Focus Anesthetic Machine FDA UDI
Model / Reference: Focus FDA UDI
Description: Focus Anesthetic Machine FDA UDI

Identifiers

Catalog Number: Focus FDA UDI
Primary DI / UDI-DI: 10841522100031 FDA UDI
FDA Product Code: BSZ FDA UDI
CBK FDA UDI
GMDN Term: Anaesthesia unit, mobile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5160 FDA UDI
868.5895 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Anaesthesia unit, mobile

BleaseFocus by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Spacelabs Healthcare (washington), Inc

Sources (1)

FDA UDI 151cc57f-c113-4e0b-866e-c4ea3baba6df 34 fields · synced Jun 8, 2026