RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Address:645 Maryville Centre Drive, Suite 200,Saint Louis,MO,63141,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

Blood Pressure Cuff (DXQ) (7) Marker, Skin (FZZ) (2) Central Venous Catheter Tray (OFF) (1)

Premarket Exempt

No Yes

Clear

Regard™ - 20326053102633 Catalog Number :

Device Class : 1

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : FZZ

Prescription Use : No

Device Count : 1

Regard™ - 20326053102640 Catalog Number :

Device Class : 1

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : FZZ

Prescription Use : No

Device Count : 1

Regard™ - 20326053104309 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Regard™ - 20326053104316 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Regard™ - 20326053104323 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Regard™ - 20326053104330 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Regard™ - 20326053104347 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Regard™ - 20326053104354 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Regard™ - 20326053104361 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Regard™ - 20326053105160 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : OFF

Prescription Use : No

Device Count : 1

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