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Spacelabs Healthcare

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
Spacelabs Healthcare FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
STARTER KIT,NELLCOR,SPO2 & NIBP,ADULT,91330 FDA UDI
Model / Reference
91330 FDA UDI
Description
STARTER KIT,NELLCOR,SPO2 & NIBP,ADULT,91330 FDA UDI

Identifiers

Catalog Number
718-0025-00 FDA UDI
Primary DI / UDI-DI
10841522105005 FDA UDI
510(k) Number
K093802 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Pulse oximeter probe, reusable 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Category: Pulse oximeter probe, reusable

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

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K093802 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 4ff55d9b-57d7-4431-bea4-2439bc667d36 35 fields · synced May 30, 2026