CARILEX MEDICAL, INC.

Address:No. 77, Keji 1st Rd.,Guishan District Taoyuan,TW

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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

Bed, Flotation Therapy, Powered (IOQ) (5) Negative Pressure Wound Therapy Powered Suction Pump (OMP) (4) Mattress, Air Flotation, Alternating Pressure (FNM) (1)

Premarket Exempt

No Yes

Clear

NA - 04713616091336 Catalog Number :

Device Description : VT Spiral Dressing Kit Black Lock

Device Class :

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616091350 Catalog Number :

Device Description : VT Drape and Port Set Kit S Lock

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616091381 Catalog Number :

Device Description : VT Drape and Port Set Kit M Lock

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616091411 Catalog Number :

Device Description : VT Drape and Port Set Kit L Lock

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616091558 Catalog Number :

Device Description : Relief Aire LAL M-set 54'' × 84'' QLT H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091619 Catalog Number :

Device Description : Relief Aire LAL M-set 36'' × 80'' QLT H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091626 Catalog Number :

Device Description : Relief Aire LAL M-set 36'' × 84'' QLT H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091633 Catalog Number :

Device Description : Relief Aire LAL M-set 42'' × 80'' QLT H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091640 Catalog Number :

Device Description : Relief Aire LAL M-set 48'' × 80'' QLT H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091657 Catalog Number :

Device Description : Lagniappe M-set 35.5" x 83" QLT Blower FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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