Tube, Collection, Capillary Blood

Device Code: 2283

Product Code(s): GIO

Device Classification Information

• Device Type ID: 2283
• Device Name: Tube, Collection, Capillary Blood
• Regulation Description: Capillary Blood Collection Tube.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Center For Biologics Evaluation & Research (CBER)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.6150 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: GIO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2283
• Device: Tube, Collection, Capillary Blood
• Product Code: GIO
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Capillary Blood Collection Tube.
• CFR Regulation Number: 864.6150 [🔎]

Device Problems
Break	2
Material Integrity Problem	1
Total Device Problems	3

TPLC Last Update: 2019-04-02 20:08:53