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Abp

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
ABP FDA UDI
Generic Name
Blood pressure ambulatory recorder FDA UDI
Device Name
LOANER - ABP ONTRAK MONITOR, MULTI-LINGUAL FDA UDI
Model / Reference
90227 FDA UDI
Description
LOANER - ABP ONTRAK MONITOR, MULTI-LINGUAL FDA UDI

Identifiers

Catalog Number
L-90227-1 FDA UDI
Primary DI / UDI-DI
10841522107719 FDA UDI
510(k) Number
K141113 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
Not 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

No

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

No

FDA UDI

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

Cleared under the same submission

K141113 also covers:

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 e7cf4a22-9fd7-4c2b-b542-8216c23cfffd 37 fields · synced Jun 1, 2026