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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
Sevoflurane anaesthesia vaporizer FDA UDI
Device Name
DATUM+ BLEASE SEVO 8% TEC QUIK-FIL FDA UDI
Model / Reference
DATUM FDA UDI
Description
DATUM+ BLEASE SEVO 8% TEC QUIK-FIL FDA UDI

Identifiers

Catalog Number
13062318 FDA UDI
Primary DI / UDI-DI
10841522118791 FDA UDI
510(k) Number
K942799 FDA UDI
FDA Product Code
CAD FDA UDI
GMDN Term
Sevoflurane anaesthesia vaporizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5880 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

No

FDA UDI

Category: Sevoflurane anaesthesia vaporizer

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

Similar devices

Also classified as Sevoflurane anaesthesia vaporizer.

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 7db36459-ea22-4834-8874-4e85c1b65b7e 36 fields · synced May 30, 2026