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

Set, Blood Transfusion (BRZ) (10) Syringe, Piston (FMF) (10)

Premarket Exempt

No Yes

Clear

N/A - 00817827022074 Catalog Number : 03-960-32

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

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022081 Catalog Number : 03-960-33

Device Description : Neonatal/Pediatric Transfer Set 150µ filter and syringe adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022098 Catalog Number : 03-960-33F

Device Description : Neonatal/Pediatric Syringe Set: 150µ filter and Syringe Adapter; not manufacture Neonatal/Pediatric Syringe Set: 150µ filter and Syringe Adapter; 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 - 00817827022104 Catalog Number : 03-960-34

Device Description : Neonatal/Pediatric Syringe Set 150µ filter and port adapter

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022111 Catalog Number : 03-960-35

Device Description : Neonatal/Pediatric Syringe Set 150µ and 35cc syringe

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022128 Catalog Number : 03-960-35F

Device Description : Neonatal/Pediatric Syringe Set 150µ filter and 35cc 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 - 00817827022135 Catalog Number : 03-960-37

Device Description : Neonatal/Pediatric Syringe Set 150µ filter and 60cc syringe

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

N/A - 00817827022142 Catalog Number : 03-960-37F

Device Description : Neonatal/Pediatric Syringe Set 150µm filter and 60cc 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 - 00817827022159 Catalog Number : 03-960-37FX

Device Description : Neonatal/Pediatric Syringe Set 150µm filter and 60cc 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 - 00817827022173 Catalog Number : 03-960-62

Device Description : Neonatal/Pediatric Transfer Set 150µ filter and syringe adapters

Device Class : 2

Duns Number: 029062325

Premarket Exempt : No

Product Code : FMF, BRZ

Prescription Use : Yes

Device Count : 1

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