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

Needle, Hypodermic, Single Lumen (FMI) (10) Set, Administration, Intravascular (FPA) (1)

Premarket Exempt

No Yes

Clear

K-SHIELD ADVANTAGE PHLEBOTOMY SET WITH ANTINEEDLE STICK PROTECTOR - 00646311000874 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 1

WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER - 00646311400018 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 1

WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER - 00646311400025 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 1

WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER - 00646311400032 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 1

WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER - 00646311400056 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 1

WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER - 00646311400063 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 1

WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER - 00646311400070 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 1

WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER - 00646311400087 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 1

WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER - 00646311400094 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 1

K-SHIELD WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER - 00646311400193 Catalog Number :

Device Class : 2

Duns Number: 690625850

Premarket Exempt : Yes

Product Code : FPA, FMI

Prescription Use : No

Device Count : 1

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