DEVICE: SpiraLith Ca (00860008449870)

Device Identifier (DI) Information

SpiraLith Ca
Rx-3616C
In Commercial Distribution

Micropore, Inc.
00860008449870
GS1

1
042903703 *Terms of Use
No description.
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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?
42414 Carbon dioxide absorber, single-use
A non-sterile, prefilled, sealed container (i.e., a canister with connectors) that constitutes a complete anaesthesia absorber, which is intended to be placed in an anaesthesia unit/workstation breathing circuit for the removal of carbon dioxide (CO2) exhaled by the patient. It is filled by the manufacturer with an appropriate carbon dioxide absorbent (e.g., granules of treated soda lime) to chemically remove CO2. A drain may be included to channel water accumulated from expired-gas moisture or other source. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CBL Absorbent, Carbon-Dioxide
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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

1591c9ce-b0e8-42f8-abd2-06fea1698435
June 05, 2025
1
May 28, 2025
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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
10860008449877 8 00860008449870 In Commercial Distribution
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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
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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