DEVICE: Soft-Release-O (07613117010386)

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Device Identifier (DI) Information

Soft-Release-O
S3061
S3061
Ypsomed AG
07613117010386
GS1
10
Soft-Release-O Infusion Set, 6 mm soft cannula, 30 cm (12") blue tubing. / Infusion set with a soft cannula designed to work with the DANA DIABECARE insulin pump.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electric infusion pump administration set, single-use A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FPA Set, administration, intravascular
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 6.0 Millimeter
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Device Status

In Commercial Distribution
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
07613117010393 10 07613117010386 In Commercial Distribution SHIPPER BOX
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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: 07613117017347 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(866)747-6645
support@sooilusa.com
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