DEVICE: Beeline motIV (00857362007020)

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Device Record History
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Device Identifier (DI) Information
Beeline motIV
BL1D00/6
In Commercial Distribution

Rex Pj Tech LLC
00857362007020
GS1

1
096931706 *Terms of Use
Infusion Set (0.6 ml/hr)
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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?
62713 Prefilled mechanical infusion pump/catheter
A device intended to be used in a clinical setting for continuous localized infusion of a dose of analgesic medication (e.g., ropivacaine), using a non-electric/non-elastic mechanical infusion pump, for regional anaesthesia and postoperative pain management. It consists of a mechanical infusion pump prefilled with medication, tubing line, and infusion catheter. The infusion catheter is intended to be inserted into the wound site during surgery and connected to the pump via the tubing line for infusion of the drug. The pump can be worn by the patient during the treatment course. The device is discarded when the medication is exhausted (single-use).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FRN Pump, Infusion
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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
27cc8c6b-d43f-44da-9801-e31d4381dafc
April 03, 2024
2
January 04, 2021
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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
10857362007027 10 00857362007020 In Commercial Distribution cardboard box
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Secondary DI

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

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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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