DEVICE: Curaplex (00810071633607)

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Device Record History
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Device Identifier (DI) Information
Curaplex
1071-11106
In Commercial Distribution
1071-11106
BOUND TREE MEDICAL, LLC
00810071633607
GS1

1
070556204 *Terms of Use
CURAPLEX DISPENSER FOR EMESIS BAG, HOLDS 25 6EA/CS
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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?
36258 Emesis bag
A disposable device intended to collect and contain a patient's vomit until it is convenient to dispose of it and its contents. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FNY BASIN, EMESIS
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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
9847f816-ec70-48bd-ac48-a35c14f08516
January 09, 2023
1
December 30, 2022
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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
00810071633737 1 00810071633607 In Commercial Distribution EA
00810071633805 6 00810071633737 In Commercial Distribution CS
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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)

[?]
Yes
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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