DEVICE: Monoject (10884527002887)

Device Identifier (DI) Information

Monoject
8881301314
Not in Commercial Distribution
8881301314
Cardinal Health, Inc.
10884527002887
GS1
June 30, 2023
100
080935429 *Terms of Use
Blood Collection Tube,Silicone Coated Tube, Glycerine Coated Red Stopper, No Additive, 4 mL Draw
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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?
37563 Non-evacuated blood collection tube IVD, no additive
A non-evacuated glass or plastic tube, sealed with a stopper, containing no additive and intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GIM Tubes, vacuum sample, with anticoagulant
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry; Fragile;AVOID DIRECT SUNLIGHT
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 10.25 Millimeter
Total Volume: 4 Milliliter
Length: 82 Millimeter
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Device Record Status

3a0a3191-b3ad-48e7-9177-64780cedbc6f
June 30, 2023
8
September 24, 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
20884527002884 1000 10884527002887 2023-06-30 Not in Commercial Distribution CASE
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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: 30884527002881 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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