DEVICE: Monoject (10884521002494)

Device Identifier (DI) Information

Monoject
8881412012
Not in Commercial Distribution
8881412012
Cardinal Health, Inc.
10884521002494
GS1
July 01, 2023
50
080935429 *Terms of Use
Curved Tip Syringes,12 mL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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?
35390 Irrigation syringe
A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMF Syringe, piston
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FDA Premarket Submission

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

Sterilization

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

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

[?]
Size Type Text
Total Volume: 12 Milliliter
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Device Record Status

a963060f-2114-4532-a270-86a9234cb4db
July 03, 2023
7
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
20884521002491 500 10884521002494 2023-07-01 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: 30884521002498 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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