DEVICE: Vacuette (29120017571166)

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Device Record History
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Device Identifier (DI) Information
Vacuette
454209
In Commercial Distribution
454209
Greiner Bio-One GmbH
29120017571166
GS1

50
303639066 *Terms of Use
VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-black ring, non-ridged
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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?
43865 Evacuated blood collection tube IVD, K2EDTA
A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening)]. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
PJE Blood/plasma collection device for DNA testing
JKA Tubes, vials, systems, serum separators, blood collection
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
BK030032 000
BK040018 000
K014104 000
K971236 000
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
45274023-5d4c-428e-b411-df137c518189
July 06, 2018
3
September 23, 2016
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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
39120017571163 24 29120017571166 In Commercial Distribution
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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: 19120017571169 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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