AMSINO INTERNATIONAL, INC.

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

Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (9) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

RECEPTAL™ 1000ML DISPOSABLE LINER WITH VAC-GARD® AND POUR SPOUT - 10704411000105 Catalog Number : 0L2139701

Device Description : RECEPTAL™ 1000ML DISPOSABLE LINER WITH VAC-GARD® AND POUR SPOUT

Device Class :

Duns Number: 825673239

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : Yes

Device Count : 1

SPECIMEN TRAP 8 INCH (20 CM) POUR SPOUT COVER - 10704411000372 Catalog Number : 433030415

Device Description : SPECIMEN TRAP 8 INCH (20 CM) POUR SPOUT COVERWITH 3/8 INCH (0.95 CM) COLLECTION SPECIMEN TRAP 8 INCH (20 CM) POUR SPOUT COVERWITH 3/8 INCH (0.95 CM) COLLECTION PORT, TETHERED CAP AND STIFFENER

Device Class : 2

Duns Number: 825673239

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

One Mask™ Oxygen Mask - 10704411000426 Catalog Number : OM001

Device Description : One Mask™ Oxygen MaskMask, Adapter, 79" (200cm) Oxygen Tubing w/Label

Device Class : 2

Duns Number: 825673239

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

RECEPTAL™ DOUBLE 1/4 INCH (0.64 CM) MALE "T", "O" RING AND SCREW - 10704411000433 Catalog Number : 443000415

Device Description : RECEPTAL™ DOUBLE 1/4 INCH (0.64 CM) MALE "T", "O" RING AND SCREW

Device Class : 2

Duns Number: 825673239

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 5

100FT (3050 CM) NON-STERILE SUCTION TUBING 0.3 INCH (0.76 CM) I.D. - 10704411000457 Catalog Number : 434550411

Device Description : 100FT (3050 CM) NON-STERILE SUCTION TUBING 0.3 INCH (0.76 CM) I.D.

Device Class : 2

Duns Number: 825673239

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

250ML ACCU-MEASURE™ RECEPTAL™ CRITICAL MEASUREMENT DEVICE - 10704411000464 Catalog Number : 433060411

Device Description : 250ML ACCU-MEASURE™ RECEPTAL™ CRITICAL MEASUREMENT DEVICE

Device Class : 2

Duns Number: 825673239

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

RECEPTAL™ 2000ML DISPOSABLE LINER WITH VAC-GARD® - 10704411000471 Catalog Number : 0G9029701

Device Description : RECEPTAL™ 2000ML DISPOSABLE LINER WITH VAC-GARD®

Device Class :

Duns Number: 825673239

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : Yes

Device Count : 1

VAC-GARD® EXTERNAL SHUTOFF VALVE - 10704411000495 Catalog Number : 433090421

Device Description : VAC-GARD® EXTERNAL SHUTOFF VALVE

Device Class : 2

Duns Number: 825673239

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVER - 10704411000648 Catalog Number : 433030412

Device Description : SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVERWITH 3/8 INCH (0.95 CM) COLLECTION SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVERWITH 3/8 INCH (0.95 CM) COLLECTION PORT, TETHERED CAP AND STIFFENER

Device Class : 2

Duns Number: 825673239

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

EZE-VAC® 18 INCH (46 CM) TANDEM TUBING - 10704411000662 Catalog Number : 433170415

Device Description : EZE-VAC® 18 INCH (46 CM) TANDEM TUBING

Device Class :

Duns Number: 825673239

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 25

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