Medex

Medex - MX920NF

A device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CBT

Device Name: Arterial Blood Sampling Kit

Device Class: 1

Physical State: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Definition: This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Submission Type ID: 7

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Regulation Number: 868.1100

Third Party Flag: N

Medical Specialty: AN

Device Id: 50351688504232

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10351688504234

Package Quantity: 100

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 10351688504234

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