DEVICE: AVENIO Millisect Fill Station (07613336146613)

Device Identifier (DI) Information

AVENIO Millisect Fill Station
08106533001
In Commercial Distribution
08106533001
Roche Molecular Systems, Inc.
07613336146613
GS1

1
071674100 *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?
62172 Laboratory waste receptacle IVD
A non-sterile container intended to collect and contain disposable materials/devices that have been contaminated due to contact with bodily fluids/substances (e.g., blood, sputum, urine, faeces) resulting from in vitro diagnostic procedures. It is typically in the form of a sack, box, or bottle made of durable plastic impervious to microorganisms. It may be used to collect solid and/or liquid waste from a laboratory instrument or analyser. This is a single-use device intended to be disposed of with its contents.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LXG EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
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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

a4377cc1-f93d-4ee7-b649-ec2906454c2b
May 08, 2020
1
April 30, 2020
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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
No Package DIs found
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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
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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