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Key Filler Bottle Adaptor MRI

FDA UDI

Class II (US FDA UDI)

by Penlon , Ltd.

Identity

Trade Name
Key Filler Bottle Adaptor MRI FDA UDI
Generic Name
Desflurane anaesthesia vaporizer FDA UDI
Device Name
Key Filler Bottle Adaptor for use with Isoflurane, Halothane & Sevoflurane in an MRI Environment FDA UDI
Model / Reference
Key Filler Bottle Adaptor MRI FDA UDI
Description
Key Filler Bottle Adaptor for use with Isoflurane, Halothane & Sevoflurane in an MRI Environment FDA UDI

Identifiers

Primary DI / UDI-DI
05051977000314 FDA UDI
510(k) Number
K053564 FDA UDI
FDA Product Code
CAD FDA UDI
GMDN Term
Desflurane 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Sevoflurane anaesthesia vaporizerDesflurane anaesthesia vaporizer

Key Filler Bottle Adaptor MRI by Penlon , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Desflurane anaesthesia vaporizer.

Cleared under the same submission

K053564 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Penlon , Ltd.

Sources (1)

  • FDA UDI ffde5559-e61d-4b55-ac3c-4a630036ab63 34 fields · synced Jun 1, 2026