CHARTER MEDICAL, LTD.

Address:3948-A WEST POINT BLVD.,Winston Salem,NC,27103,US

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Filters

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

Container, Frozen Donor Tissue Storage (LPZ) (6) Set, Blood Transfusion (BRZ) (4) Syringe, Piston (FMF) (4)

Premarket Exempt

No Yes

Clear

N/A - 00817827022180 Catalog Number : 03-BDP-30

Device Description : Neonatal/Pediatric Syringe Set 150µ Filter, 30cc Syringe, 150 mL bag

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022197 Catalog Number : 03-BDP-60

Device Description : Neonatal/Pediatric Syringe Set 150µ Filter, 50cc Syringe, 150mL bag

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022203 Catalog Number : 03-BDP-60X2

Device Description : Neonatal/Pediatric Syringe Set 150µ Filter, 60cc Syringe, 150mL bag

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022210 Catalog Number : 03-MJP-60

Device Description : Neonatal/Pediatric Syringe Set 150µ Filter, 60cc Syringe, 150mL bag

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

Cell Freeze - 00817827023019 Catalog Number : CF-250

Device Description : Cell Freeze Cryogenic Storage Container 250 mL Capacity

Device Class : U

Duns Number: 029062325

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Cell Freeze - 00817827023026 Catalog Number : CF-250-3L

Device Description : Cell Freeze Cryogenic Storage Container 250 mL Capacity

Device Class : U

Duns Number: 029062325

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Cell Freeze - 00817827023033 Catalog Number : CF-500

Device Description : Cell Freeze Cryogenic Storage Container 500 mL Capacity

Device Class : U

Duns Number: 029062325

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Cell Freeze - 00817827023040 Catalog Number : CF-500-3L

Device Description : Cell Freeze Cryogenic Storage Container 500 mL Capacity

Device Class : U

Duns Number: 029062325

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Cell Freeze - 00817827023057 Catalog Number : CF-50

Device Description : Cell Freeze Cryogenic Storage Container 50 mL Capacity

Device Class : U

Duns Number: 029062325

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Cell Freeze - 00817827023064 Catalog Number : CF-750

Device Description : Cell Freeze Cryogenic Storage Container 750 mL Capacity

Device Class : U

Duns Number: 029062325

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

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