Identity
- Trade Name
- K-Zero® FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Needleless Connector FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- M79400849 FDA UDI
- Primary DI / UDI-DI
- 04250273735949 FDA UDI
- 510(k) Number
- K162826 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Electric infusion pump administration set, single-use
K-Zero® by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI d55101a6-e69a-460d-9d42-f09bb5fc6413 36 fields · synced Jun 6, 2026