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Ultralite

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
Ultralite FDA UDI
Generic Name
Blood pressure ambulatory recorder FDA UDI
Device Name
ABP ULTRALITE MONITOR,MULTI-LINGUAL FDA UDI
Model / Reference
Ultralite FDA UDI
Description
ABP ULTRALITE MONITOR,MULTI-LINGUAL FDA UDI

Identifiers

Catalog Number
90217A-1 FDA UDI
Primary DI / UDI-DI
10841522105067 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Blood pressure ambulatory recorder FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood pressure ambulatory recorder

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

Similar devices

Also classified as Blood pressure ambulatory recorder.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spacelabs Healthcare (washington), Inc

Sources (1)

  • FDA UDI 1d8c85e7-c703-428f-ab53-339c9ee61a77 35 fields · synced Jun 1, 2026