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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
Isoflurane anaesthesia vaporizer FDA UDI
Device Name
DATUM+ ABBOTT 5% ISO TEC KEYFILL FDA UDI
Model / Reference
DATUM FDA UDI
Description
DATUM+ ABBOTT 5% ISO TEC KEYFILL FDA UDI

Identifiers

Catalog Number
13012123 FDA UDI
Primary DI / UDI-DI
10841522118500 FDA UDI
510(k) Number
K942799 FDA UDI
FDA Product Code
CAD FDA UDI
GMDN Term
Isoflurane anaesthesia vaporizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5880 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

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

No

FDA UDI

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

Cleared under the same submission

K942799 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 e78fe5b9-ecfb-4aa3-a459-02396dce2edb 37 fields · synced Jun 8, 2026