DEVICE: HSW SOFT-JECT® (04035873045786)
Device Identifier (DI) Information
HSW SOFT-JECT®
8300029522
In Commercial Distribution
8300029522
Henke-Sass, Wolf GmbH
8300029522
In Commercial Distribution
8300029522
Henke-Sass, Wolf GmbH
0,5 ML HSW SOFT-JECT® INS 100IU FIXED NEEDLE 0,30X12/30GX1/2
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
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No | |
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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? |
---|---|---|---|---|
38501 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMF | Syringe, Piston |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Protect from sunlight |
Special Storage Condition, Specify: Keep dry |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 0.5 Milliliter |
Device Record Status
2d7adc4c-c661-4558-9c40-b71284e9c98e
July 23, 2018
3
September 12, 2016
July 23, 2018
3
September 12, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
04035873045779 | 20 | 04035873045786 | In Commercial Distribution | CARTON |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04035873052937
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined