FreeStyle Precision H Blood Glucose Test Strips
FreeStyle Precision H - 80116
Device Description
A collection of devices that includes one or more portable, electrically-powered instruments (meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used together exclusively at the point-of-care by medical professionals for the quantitative measurement of more than one clinical chemistry analyte [e.g., glucose, ketones, lipid(s), and/or creatinine] in a whole blood specimen. Some types may also include measurement of haemoglobin and/or haematocrit for rapid diagnosis of anaemia and/or blood loss.
Environmental Conditions
- 86.00
- 39.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LFR
Device Name: Glucose Dehydrogenase, Glucose
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
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: 862.1345
Third Party Flag: Y
Medical Specialty: CH
Code: NBW
Device Name: System, Test, Blood Glucose, Over The Counter
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
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: 862.1345
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 30093815801161
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00093815801160
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 00093815801160
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: 57599-0116-5
Device Type: Secondary
DeviceId Issuing Agency: NDC/NHRIC
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 10093815801167
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