FDA UDI
In Commercial Distribution
🇺🇸 United States
K-Zero®
DI: 04250273735949
·
Model: Needleless Connector
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- K-Zero®
- Primary DI
- 04250273735949
- Version / Model
- Needleless Connector
- Catalog Number
- M79400849
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 1
- Public Version Date
- 2022-12-08
- Public Version Status
- New
- Public Device Record Key
- d55101a6-e69a-460d-9d42-f09bb5fc6413
Device Description
The K-Zero Neutral Needleless Connector is intended for single patient use in intravenous and blood administration and aspiration without the need for needles, thus eliminating the potential for needle-stick injuries during use. The K-Zero Neutral Needleless Connector may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The subject device does ot have to be changed subsequent to use with a low pressure power injector.
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250273735949 | GS1 | ||||
| Package | 04250273735956 | GS1 | Box | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +496621168400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162826 | 000 |