Actreen® Hi
Actreen® - 238212NA
Device Description
A sterile flexible tube inserted into the bladder, via the urethra, to obtain a sample of urine that has not been contaminated by urethral passage. The distal end can have various tip designs, and the proximal end may terminate in a soft connecting piece to connect to a urine specimen collection container. The device is applied by a healthcare provider to the patient, is typically made of polyvinyl chloride (PVC), and may or may not be coated with a lubricating substance. This is a single-use device.
Environmental Conditions
- KEEP DRY
- Keep away from sunlight
- This way up
Device Sizes
- Catheter Gauge: 12.0 French
- Charrière (catheter) : 12.000
- Outer Diameter: 4.0 Millimeter
- Length: 37 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GBM
Device Name: Catheter, Urethral
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: GU
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: 876.5130
Third Party Flag: Y
Medical Specialty: GU
Device IdentifiersDevice Id: 04046964613609
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04046964613593
Package Quantity: 16
Package Discontinue Date: 7/31/2021 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Carton
Device Id: 04046964613593
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: 04046964613586
Device Type: Unit of Use
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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