DEVICE: MaxGuard (10885403236013)

Device Identifier (DI) Information

MaxGuard
ME1050
In Commercial Distribution
ME1050
BD Switzerland Sàrl
10885403236013
GS1

1
482631558 *Terms of Use
Extension Set, (minibore) 76 cm (30 in)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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?
12170 Intravenous administration tubing extension set
A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FPA Set, administration, intravascular
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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
Special Storage Condition, Specify: Storage Temperature
Storage Environment Temperature: between -40 and 125 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Fragile, handle with care
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Clinically Relevant Size

[?]
Size Type Text
Length: 30 Inch
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Device Record Status

687a6ce6-d96a-4b4b-9e1b-2b6fe6974a44
July 04, 2025
6
September 22, 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
50885403236011 50 10885403236013 In Commercial Distribution Box
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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

[?]
+1(844)823-5433
customer_support@bd.com
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