DISTRIBUTION UNLIMITED, LLC

Address:8957 W Windsor Drive,Peoria,AZ,85381,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

Cannula, Nasal, Oxygen (CAT) (2) Mask, Gas, Anesthetic (BSJ) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1) Gauze / Sponge,Nonresorbable For External Use (NAB) (1) Tourniquet, Nonpneumatic (GAX) (1) Pack, Hot Or Cold, Disposable (IMD) (1) Set, Administration, Intravascular (FPA) (1) Container, Specimen, Sterile (FMH) (1)

Premarket Exempt

No Yes

Clear

Anesthesia Mask (Large) - 00850014433109 Catalog Number : DU1078

Device Description : are rubber or silicone masks that cover both the mouth and nose of the patient.

Device Class : 1

Duns Number: 926603486

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : No

Device Count : 1

Anesthesia Mask (Medium) - 00850014433123 Catalog Number : DU1073

Device Description : are rubber or silicone masks that cover both the mouth and nose of the patient.

Device Class : 1

Duns Number: 926603486

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : No

Device Count : 1

IV Extension Set 6" - 00850014433130 Catalog Number : DU2260

Device Description : are connected to IV catheters to allow a larger distance between the patient and are connected to IV catheters to allow a larger distance between the patient and the fluid being administered which is often necessary due to the size and volume of equipment being used at any one time

Device Class : 2

Duns Number: 926603486

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Nasal Oxygen Cannula - 00850014433154 Catalog Number : DU1010

Device Description : The nasal cannula is a device used to deliver supplemental oxygen or increased a The nasal cannula is a device used to deliver supplemental oxygen or increased airflow to a patient or person in need of respiratory help.

Device Class :

Duns Number: 926603486

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : No

Device Count : 1

Grounding Pads - 00850014433161 Catalog Number : DU2100

Device Description : A grounding pad is placed on the body (usually the thigh) before the surgery to A grounding pad is placed on the body (usually the thigh) before the surgery to protect the person from the harmful effects of the electricity.

Device Class :

Duns Number: 926603486

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ice Compress 4"x7" - 00850014433178 Catalog Number : DU1703

Device Description : Instant Ice Compress is a device that consists of two bags; one containing water Instant Ice Compress is a device that consists of two bags; one containing water, inside a bag containing ammonium nitrate, calcium ammonium nitrate or urea. When the inner bag of water is broken by squeezing the package, it dissolves the solid in an endothermic reaction.

Device Class :

Duns Number: 926603486

Premarket Exempt : Yes

Product Code : IMD

Prescription Use : No

Device Count : 1

ETCO2 Nasal Cannula - 00850014433215 Catalog Number : DU1090

Device Description : A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into th A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs.

Device Class : 1

Duns Number: 926603486

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : No

Device Count : 1

Tourniquet 1"x18" - 00850014433222 Catalog Number : DU2210

Device Description : a device for stopping the flow of blood through a vein or artery, typically by c a device for stopping the flow of blood through a vein or artery, typically by compressing a limb with a cord or tight bandage.

Device Class :

Duns Number: 926603486

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 1

Sterile Specimen Cup with Temp Strip - 00850014433239 Catalog Number : DU3100

Device Description : The urine collection cup is a sterile plastic cup with a temperature strip and l The urine collection cup is a sterile plastic cup with a temperature strip and leak-resistant lid with a capacity of 90mL. This product can be used for urine, blood, and semen sample testing.

Device Class :

Duns Number: 926603486

Premarket Exempt : Yes

Product Code : FMH

Prescription Use : No

Device Count : 1

Non Woven Sponge 2x2 4 ply - 00850014433246 Catalog Number : DU1202

Device Description : is a sterile sponge for wound dressing, prepping, and scrubbing.

Device Class :

Duns Number: 926603486

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

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