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

Tube, Tracheal (W/Wo Connector) (BTR) (6) Catheter, Retention Type, Balloon (EZL) (4)

Premarket Exempt

Yes No

Clear

Sunmed - 10889483034491 Catalog Number :

Device Description : PREFORMED NASAL CUFFED E/T TUBE 4mm 16FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034507 Catalog Number :

Device Description : PREFORMED NASAL CUFFED E/T TUBE 4.5mm 18FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034514 Catalog Number :

Device Description : PREFORMED NASAL CUFFED E/T TUBE 5mm 20FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034521 Catalog Number :

Device Description : PREFORMED NASAL CUFFED E/T TUBE 5.5mm 22FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034538 Catalog Number :

Device Description : PREFORMED NASAL CUFFED E/T TUBE 6mm 24FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034545 Catalog Number :

Device Description : PREFORMED NASAL CUFFED E/T TUBE 6.5mm 26FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483037522 Catalog Number :

Device Description : Foley Pediatric Latex 2 Way 3cc 6fr

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483037539 Catalog Number :

Device Description : Foley Pediatric Latex 2 Way 3cc 8fr

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483037546 Catalog Number :

Device Description : Foley Pediatric Latex 2 Way 3cc 10fr

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483037553 Catalog Number :

Device Description : Foley Latex 2 Way 5cc 12fr

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

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