SUNMED, LLC

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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

Stimulator, Nerve, Battery-Powered (BXN) (4) Set, Tubing And Support, Ventilator (W Harness) (BZO) (3) Ophthalmoscope, Battery-Powered (HLJ) (1) Tube, Tracheal (W/Wo Connector) (BTR) (1) Ventilator, Emergency, Manual (Resuscitator) (BTM) (1)

Premarket Exempt

No Yes

Clear

Sunmed - 10889483042250 Catalog Number :

Device Description : Opthalmoscope Lamp 2.5V

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483048108 Catalog Number :

Device Description : E/T TUBE CUFFED 2.5mm 10FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

SunMed - 10889483055557 Catalog Number :

Device Description : SUNSTIM OVERLAY

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

SunMed - 10889483055564 Catalog Number :

Device Description : SUNSTIM PLUS OVERLAY

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

SunMed - 10889483056516 Catalog Number :

Device Description : BATTERY COVER FOR SUNSTIM

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

SunMed - 10889483056523 Catalog Number :

Device Description : BATTERY COVER FOR SUNSTIM PLUS

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

AirFlow - 10889483232088 Catalog Number :

Device Description : Infant Resuscitator with Corrugated Tubing, Manometer, Filter, 40cm H2O Pop-Off Infant Resuscitator with Corrugated Tubing, Manometer, Filter, 40cm H2O Pop-Off & Size 0, 1 & 2 Masks

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

SunMed - 20889483228804 Catalog Number :

Device Description : Adult Mask Harness

Device Class : 1

Duns Number: 069009268

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

SunMed - 20889483228811 Catalog Number :

Device Description : Child Mask Harness

Device Class : 1

Duns Number: 069009268

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

SunMed - 20889483228828 Catalog Number :

Device Description : Infant Mask Harness

Device Class : 1

Duns Number: 069009268

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

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