DEVICE: Tubing 2M Single (07612367051132)

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Device Record History
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Device Identifier (DI) Information
Tubing 2M Single
080.0051
In Commercial Distribution

Medela AG
07612367051132
GS1

1
488293218 *Terms of Use
Tubing 2 M Single. Model No. MAJ-103 K. 3920733
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
16779 Suction/irrigation tubing, single-use
A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BTA Pump, Portable, Aspiration (Manual Or Powered)
QPB System, Suction, Lipoplasty For Removal
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K150134 000
K170329 000
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
b25cd765-ac43-48a2-b476-795edbc86da0
May 31, 2022
8
June 07, 2017
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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
07612367007061 50 07612367051132 In Commercial Distribution 080.0050
07612367010719 50 07612367051132 2022-05-31 Not in Commercial Distribution 080.0051
07612367078214 15 07612367051132 In Commercial Distribution 080.0051
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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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