DEVICE: Dash 6 (05060498306959)

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Device Record History
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Device Identifier (DI) Information
Dash 6
15200001
In Commercial Distribution
15200001
INTERVENE GROUP LIMITED
05060498306959
GS1

1
735285129 *Terms of Use
Dash 6, Epidural Catheter Feeder, NRFit® Accessories, Single Use
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Device Characteristics
MR Safe
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?
63607 NRFit/epidural catheter linear connector
A small, non-powered, noninvasive, tubular device with an NRFit connection at one end (a connection designed specifically for neuraxial applications according to ISO 80369-6) and an epidural catheter adapting mechanism at the other end, intended to connect an external device with an NRFit connection (e.g., syringe) with an epidural catheter with no pre-existing connector. It is designed to connect over the epidural catheter and seal the connection with either an integrated clamping mechanism or by means of an adhesive port. It does not incorporate a valve, tubing nor puncturing component. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BSO CATHETER, CONDUCTION, ANESTHETIC
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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
39495c26-3be6-4079-9f89-d5747b4cd85f
June 12, 2023
1
June 02, 2023
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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
05060498302173 15 05060498302166 In Commercial Distribution Case
05060498302166 1000 05060498306959 In Commercial Distribution Box
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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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