FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HSW SOFT-JECT®
DI: 04035873046509
·
Model: 8300030253
·
Henke-Sass, Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- HSW SOFT-JECT®
- Primary DI
- 04035873046509
- Version / Model
- 8300030253
- Catalog Number
- 8300030253
- Company Name
- Henke-Sass, Wolf GmbH
- Labeler DUNS
- 317326411
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 5
- Public Version Date
- 2019-03-15
- Public Version Status
- Update
- Public Device Record Key
- 73ceaac3-17f5-4462-ac45-f4ef693f8134
- Distribution End Date
- 2019-03-11
Device Description
50ML (60ML) HSW SOFT-JECT® PERFUSION AMBER AK 2,00X30MM / 14GX1 1/4
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 |
|---|---|---|---|---|
| 47017 | General-purpose syringe, single-use | A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04035873046493 | GS1 | CARTON | 6 | Not in Commercial Distribution | 2019-03-11 |
| Primary | 04035873046509 | GS1 | ||||
| Unit of Use | 04035873053248 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 50 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry