K
K-Pack II - KN-2713RBKT50
Device Description
A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.
Environmental Conditions
- Do not store at extreme temperature and humidity.
Device Sizes
- Needle Length: 12 Millimeter
- Needle Outer Diameter: 0.4 Millimeter
- Needle Length: 0.5 Inch
- Needle Gauge: 27 Gauge
- Thin Wall
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FMI
Device Name: Needle, Hypodermic, Single Lumen
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.5570
Third Party Flag: Y
Medical Specialty: HO
Device IdentifiersDevice Id: 55413206211956
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35413206211952
Package Quantity: 50
Package Discontinue Date: 5/7/2018 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Carton
Device Id: 35413206211952
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05413206211951
Package Quantity: 50
Package Discontinue Date: 5/7/2018 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Shelfbox
Device Id: 05413206211951
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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