BOUND TREE MEDICAL, LLC

Address:2911 S GREAT SW PARKWAY,Grand Prairie,TX,75052,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

Oral Airway Assist (PHS) (5) CATHETERS, SUCTION, TRACHEOBRONCHIAL (BSY) (5) Changer, tube, endotracheal (LNZ) (5) Cardiopulmonary resuscitation aid kit (OEV) (1) ACCESSORY, SURGICAL APPAREL (LYU) (1) Cricothyrotomy kit (OGP) (1) First aid kit without drug (OHO) (1) Body fluids barrier kit (OKH) (1) I.V. start kit (LRS) (1)

Premarket Exempt

No Yes

Clear

Curaplex - 00810071632402 Catalog Number : 8600-01484

Device Description : *Custom* Curaplex CVCC PPE Kit

Device Class : 1

Duns Number: 070556204

Premarket Exempt : Yes

Product Code : LYU, OKH

Prescription Use : Yes

Device Count : 1

Curaplex - 00810071632419 Catalog Number : 8600-01486

Device Description : *Custom* Curaplex GAEMS Cric Kit

Device Class : 2

Duns Number: 070556204

Premarket Exempt : Yes

Product Code : OGP

Prescription Use : Yes

Device Count : 1

Curaplex - 00810071633027 Catalog Number : 670244-KIT

Device Description : Curaplex IV Start Kit with Tegaderm, Chloraprep, Tape

Device Class :

Duns Number: 070556204

Premarket Exempt : Yes

Product Code : LRS

Prescription Use : Yes

Device Count : 1

Curaplex - 00810071633065 Catalog Number : 8600-01485

Device Description : *Custom* Curaplex LTR IFAK

Device Class : 1

Duns Number: 070556204

Premarket Exempt : Yes

Product Code : OHO

Prescription Use : Yes

Device Count : 1

Curaplex - 00810071633072 Catalog Number : 8600-01487

Device Description : *Custom* Curaplex Northwell BVM Kit

Device Class : 2

Duns Number: 070556204

Premarket Exempt : Yes

Product Code : OEV

Prescription Use : Yes

Device Count : 1

Curaplex - 00810071633133 Catalog Number : 8600-01490

Device Description : *Custom* Curaplex Children's Hospital Kit Purple Pouch

Device Class : 1

Duns Number: 070556204

Premarket Exempt : Yes

Product Code : BSY, PHS, LNZ

Prescription Use : No

Device Count : 1

Curaplex - 00810071633140 Catalog Number : 8600-01491

Device Description : *Custom* Curaplex Children's Hospital Kit Red Pouch

Device Class : 1

Duns Number: 070556204

Premarket Exempt : Yes

Product Code : PHS, BSY, LNZ

Prescription Use : No

Device Count : 1

Curaplex - 00810071633157 Catalog Number : 8600-01492

Device Description : *Custom* Curaplex Children's Hospital Kit White Pouch

Device Class : 1

Duns Number: 070556204

Premarket Exempt : Yes

Product Code : LNZ, PHS, BSY

Prescription Use : No

Device Count : 1

Curaplex - 00810071633164 Catalog Number : 8600-01493

Device Description : *Custom* Curaplex Children's Hospital Kit Yellow Pouch

Device Class : 1

Duns Number: 070556204

Premarket Exempt : Yes

Product Code : BSY, LNZ, PHS

Prescription Use : No

Device Count : 1

Curaplex - 00810071633171 Catalog Number : 8600-01494

Device Description : *Custom* Curaplex Children's Hospital Kit Blue Pouch

Device Class : 1

Duns Number: 070556204

Premarket Exempt : Yes

Product Code : PHS, LNZ, BSY

Prescription Use : No

Device Count : 1

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