SB-KAWASUMI LABORATORIES, INC.

Address:3-25-4 Tonomachi,,Kawasaki-shi Kanagawa,JP

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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, Administration, Intravascular (FPA) (10)

Premarket Exempt

Yes No

Clear

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET - 00646311552991 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : No

Device Count : 1

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET - 00646311553004 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : No

Device Count : 1

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET - 00646311553011 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : No

Device Count : 1

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET - 00646311553028 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : No

Device Count : 1

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET - 00646311553035 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : No

Device Count : 1

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET - 00646311553042 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : No

Device Count : 1

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET - 00646311553059 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : No

Device Count : 1

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET - 00646311553066 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : No

Device Count : 1

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET - 00646311553073 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : No

Device Count : 1

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET - 00646311553080 Catalog Number : PA03090

Device Description : K-Shield Advantage Port Access Infusion Set is an intravascular administration s K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncoring Huber needle that is used to access an implanted medication port for solution infusion.The Port Access Infusion Set is designed with an integral safety device intended to protect against accidental needlestick injuries when removing the device from the implanted port.

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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