FDA UDI
In Commercial Distribution
🇺🇸 United States
HSW SOFT-JECT®
DI: 04035873021803
·
Model: 5100.X00V0
·
Henke-Sass, Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- HSW SOFT-JECT®
- Primary DI
- 04035873021803
- Version / Model
- 5100.X00V0
- Catalog Number
- 5100.X00V0
- Company Name
- Henke-Sass, Wolf GmbH
- Labeler DUNS
- 317326411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 3
- Public Version Date
- 2018-07-23
- Public Version Status
- Update
- Public Device Record Key
- 5c09347e-7f10-4b8d-a7e1-9798ff18d4cd
Device Description
10 ML (12 ML) HSW SOFT-JECT® LUER LOCK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35904 | Metered-delivery hypodermic syringe | A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04035873021797 | GS1 | CARTON | 12 | In Commercial Distribution | |
| Primary | 04035873021803 | GS1 | ||||
| Unit of Use | 04035873051336 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 10 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry