AMSINO INTERNATIONAL, INC.

Address:708 Corporate Center Dr,POMONA,CA,91768,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

Tubes, Gastrointestinal (And Accessories) (KNT) (7) Dressing, Wound, Drug (FRO) (2) Saline, Vascular Access Flush (NGT) (1)

Premarket Exempt

No Yes

Clear

PUGGLE™ G-Tube - 00704411007282 Catalog Number : PLG16-10

Device Description : PUGGLE™ G-Tube16 Fr. 10 mL GASTROSTOMY TUBE WITH Y-PORTS

Device Class : 2

Duns Number: 825673239

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

PUGGLE™ G-Tube - 00704411007299 Catalog Number : PLG16-20

Device Description : PUGGLE™ G-Tube16 Fr. 20 mL GASTROSTOMY TUBE WITH Y-PORTS

Device Class : 2

Duns Number: 825673239

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

PUGGLE™ G-Tube - 00704411007305 Catalog Number : PLG18-20

Device Description : PUGGLE™ G-Tube18 Fr. 20 mL GASTROSTOMY TUBE WITH Y-PORTS

Device Class : 2

Duns Number: 825673239

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

PUGGLE™ G-Tube - 00704411007312 Catalog Number : PLG20-10

Device Description : PUGGLE™ G-Tube20 Fr. 10 mL GASTROSTOMY TUBE WITH Y-PORTS

Device Class : 2

Duns Number: 825673239

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

PUGGLE™ G-Tube - 00704411007329 Catalog Number : PLG20-20

Device Description : PUGGLE™ G-Tube20 Fr. 20 mL GASTROSTOMY TUBE WITH Y-PORTS

Device Class : 2

Duns Number: 825673239

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

PUGGLE™ G-Tube - 00704411007336 Catalog Number : PLG22-20

Device Description : PUGGLE™ G-Tube22 Fr. 20 mL GASTROSTOMY TUBE WITH Y-PORTS

Device Class : 2

Duns Number: 825673239

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

PUGGLE™ G-Tube - 00704411007343 Catalog Number : PLG24-20

Device Description : PUGGLE™ G-Tube24 Fr. 20 mL GASTROSTOMY TUBE WITH Y-PORTS

Device Class : 2

Duns Number: 825673239

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

AMSure® Sterile Normal Saline for Wound Flush - 00704411007442 Catalog Number : AS398

Device Description : AMSure® Sterile Normal Saline for Wound Flush devices are wound and device clean AMSure® Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and fordevice irrigation. Sterile normal saline for wound flush are intended to be used in clinical and should only be used by clinicians familiar with the treatment of possiblecomplications.

Device Class :

Duns Number: 825673239

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

AMSure® Sterile Water for Wound Flush - 00704411007459 Catalog Number : AS399

Device Description : AMSure® Sterile Water for Wound Flush devices are wound and device cleaning solu AMSure® Sterile Water for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for deviceirrigation. Sterile Water for wound flush are intended to be used in clinical care and should only be used by clinicians familiar with the treatment of possible complications.

Device Class :

Duns Number: 825673239

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

AMSafe® Pre-Filled Normal Saline Flush Syringe - 00704411009934 Catalog Number : IVF1203

Device Description : 0.9% Sodium Chloride Injection, USPSterile Fluid & PathDo Not Place Syringe on a 0.9% Sodium Chloride Injection, USPSterile Fluid & PathDo Not Place Syringe on a Sterile Field3 mL Fill • Preservative Free

Device Class :

Duns Number: 825673239

Premarket Exempt : No

Product Code : NGT

Prescription Use : Yes

Device Count : 1

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