DEVICE: HSW SOFT-JECT® (04035873030539)

Device Identifier (DI) Information

HSW SOFT-JECT®
8300010170
In Commercial Distribution
8300010170
Henke-Sass, Wolf GmbH
04035873030539
GS1

100
317326411 *Terms of Use
1 ML HSW SOFT-JECT® INS 100IU FIXED NEEDLE 0,30X12/30GX1/2
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
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
Insulin syringe/needle, basic A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.
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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

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

[?]
Storage and Handling
Special Storage Condition, Specify: Protect from sunlight
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 1 Milliliter
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Device Record Status

3d040586-188d-4679-a0d0-98a2205cb964
March 29, 2018
2
September 05, 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
04035873030522 20 04035873030539 In Commercial Distribution CARTON
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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

[?]
Unit of Use DI Number: 04035873050353 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
9999999999
info@henkesasswolf.de
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