FDA UDI
In Commercial Distribution
🇺🇸 United States
HSW HENKE-JECT®
DI: 04035873060017
·
Model: 8300005458
·
Henke-Sass, Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
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Basic Information
- Brand Name
- HSW HENKE-JECT®
- Primary DI
- 04035873060017
- Version / Model
- 8300005458
- Catalog Number
- 8300005458
- Company Name
- Henke-Sass, Wolf GmbH
- Labeler DUNS
- 317326411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2020-01-17
- Public Version
- 1
- Public Version Date
- 2020-01-27
- Public Version Status
- New
- Public Device Record Key
- e1fee332-ca1c-41bf-8cc7-b0d0f5613066
Device Description
HSW HENKE-JECT® 3-TLG. 100 ML (120 ML) CATHETER
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 |
|---|---|---|---|---|
| 35390 | Irrigation syringe | A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04035873060024 | GS1 | CARTON | 6 | In Commercial Distribution | |
| Primary | 04035873060017 | GS1 | ||||
| Unit of Use | 04035873060000 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 100 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- PROTECT FROM SUNLIGHT,KEEP DRY