CHARTER MEDICAL, LTD.

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

Set, Blood Transfusion (BRZ) (6) Syringe, Piston (FMF) (6) Set, Transfer (Blood/Plasma) (KSB) (4)

Premarket Exempt

Yes No

Clear

N/A - 00817827021121 Catalog Number : 03-220-BD

Device Description : Plasma/Fluid Transfer Set with Tube Adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

N/A - 00817827021138 Catalog Number : 03-220-TM

Device Description : Plasma/Fluid Transfer Set 12" tubing with needle assembly and 100mL bag

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

N/A - 00817827021145 Catalog Number : 03-220-TMBC

Device Description : Plasma/Fluid Transfer Set 100 mL Bag, 12 mL Syringe and Adapter Cap Assembly

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

N/A - 00817827021152 Catalog Number : 03-220-XL

Device Description : Plasma Transfer Set 5mL Syringe with Tubing Assembly

Device Class :

Duns Number: 029062325

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

N/A - 00817827022012 Catalog Number : 03-960-00

Device Description : Plasma Transfer Sets 4" tubing with female luer adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022029 Catalog Number : 03-960-00F

Device Description : Neonatal/Pediatric Syringe Set: 150µ filter and 30cc syringe; not manufactured with DEHP

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022036 Catalog Number : 03-960-10

Device Description : Neonatal/Pediatric Syringe Set 150µ filter and 50cc syringe

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022043 Catalog Number : 03-960-10F

Device Description : Neonatal/Pediatric Syringe Set: 150µ filter and 50cc syringe; not manufactured with DEHP

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022050 Catalog Number : 03-960-10FX

Device Description : Neonatal/Pediatric Syringe Set: 150µ filter and 50cc syringe. Not Manufactured with DEHP

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022067 Catalog Number : 03-960-10X3

Device Description : Neonatal/Pediatric Syringe Set 150µ and 50cc syringe

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

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