Medex - 460000
Device Description
A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: True
Sterilization Methods:
- Ethylene Oxide
Product Codes
Code: FPA
Device Name: Set, Administration, Intravascular
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: 880.5440
Third Party Flag: Y
Medical Specialty: HO
Device IdentifiersDevice Id: 30351688516477
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10351688516473
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 10351688516473
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
Device Id: 50351688516471
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 30351688516477
Package Quantity: 200
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE