DEVICE: Personal Device Holder (00848530087777)

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Device Record History
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Device Identifier (DI) Information
Personal Device Holder
CSBD2Roller
In Commercial Distribution

SUNSET HEALTHCARE SOLUTIONS, INC.
00848530087777
GS1

1
141668116 *Terms of Use
Cylinder Roller Bag — Dual D/E Tank
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
64875 Home CPAP/BPAP washer/disinfector device container
A bag-like device intended for use with a home CPAP/BPAP washer/disinfector for the cleaning/disinfection of home positive airway pressure masks (e.g., CPAP/BPAP oral mask) using ozone gas as the disinfecting agent. It consists of a polymer receptacle that connects to the main washer/disinfector unit and in which the devices to be cleaned are placed for immersion in the cleaning medium; it includes an exhaust gas filter. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAN Regulator, Pressure, Gas Cylinder
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ce29d51f-2f70-44bb-bab5-dd99c042b829
June 27, 2024
1
June 19, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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