K2 Scientific, LLC

Address:3029 Horseshoe Lane Suite D,Charlotte,NC,28208,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Refrigerator, Freezer, Blood Storage (KSE) (10)

Premarket Exempt

Yes

Clear

K2 Scientific, LLC - G136K212GDRBB0 Catalog Number : K212GDR-BB

Device Description : 14 Cu. Ft. High-Performance Laboratory Blood Bank Refrigerator. Features an int 14 Cu. Ft. High-Performance Laboratory Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K212GDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

Device Class : 2

Duns Number: 080936069

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

K2 Scientific, LLC - G136K215SDFBBBF0 Catalog Number : K215SDF-BB-BF

Device Description : 15 Cu. Ft., Solid Door, Blood Bank, High-Performance, Plasma Blast Freezer

Device Class : 2

Duns Number: 080936069

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

K2 Scientific, LLC - G136K225GDRBB0 Catalog Number : K225GDR-BB

Device Description : 25 Cu. Ft. High-Performance Laboratory Glass Door Blood Bank Refrigerator. Feat 25 Cu. Ft. High-Performance Laboratory Glass Door Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225GDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

Device Class : 2

Duns Number: 080936069

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

K2 Scientific, LLC - G136K225GDRSSBB0 Catalog Number : K225GDR-SS-BB

Device Description : 25 Cu. Ft. High-Performance Laboratory, Glass Door, Stainless Steel, Blood Bank 25 Cu. Ft. High-Performance Laboratory, Glass Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225GDR-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

Device Class : 2

Duns Number: 080936069

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

K2 Scientific, LLC - G136K225SDFBB0 Catalog Number : K225SDF-BB

Device Description : 25 Cu. Ft. High-Performance Laboratory, Solid Door, Blood Bank Freezer. Feature 25 Cu. Ft. High-Performance Laboratory, Solid Door, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDF-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

Device Class : 2

Duns Number: 080936069

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

K2 Scientific, LLC - G136K225SDFSSBB0 Catalog Number : K225SDF-SS-BB

Device Description : 25 Cu. Ft. High-Performance Laboratory, Solid Door, Stainless Steel, Blood Bank 25 Cu. Ft. High-Performance Laboratory, Solid Door, Stainless Steel, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDF-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

Device Class : 2

Duns Number: 080936069

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

K2 Scientific, LLC - G136K225SDRBB0 Catalog Number : K225SDR-BB

Device Description : 25 Cu. Ft. High-Performance Laboratory Solid Door Blood Bank Refrigerator. Feat 25 Cu. Ft. High-Performance Laboratory Solid Door Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

Device Class : 2

Duns Number: 080936069

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

K2 Scientific, LLC - G136K225SDRSSBB0 Catalog Number : K225SDR-SS-BB

Device Description : 25 Cu. Ft. High-Performance Laboratory, Solid Door, Stainless Steel, Blood Bank 25 Cu. Ft. High-Performance Laboratory, Solid Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDR-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

Device Class : 2

Duns Number: 080936069

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

K2 Scientific, LLC - G136K230GDRBB0 Catalog Number : K230GDR-BB

Device Description : 30 Cu. Ft. High-Performance Laboratory, Glass Door, Blood Bank Refrigerator. Fe 30 Cu. Ft. High-Performance Laboratory, Glass Door, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K230GDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

Device Class : 2

Duns Number: 080936069

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

K2 Scientific, LLC - G136K230GDRSSBB0 Catalog Number : K230GDR-SS-BB

Device Description : 30 Cu. Ft. High-Performance Laboratory Glass Door, Stainless Steel, Blood Bank 30 Cu. Ft. High-Performance Laboratory Glass Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K230GDR-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

Device Class : 2

Duns Number: 080936069

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

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