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) (9) Catheter, Retention Type, Balloon (EZL) (1)

Premarket Exempt

Yes No

Clear

Sunmed - 10889483021118 Catalog Number :

Device Description : E/T TUBE NO-CUFF 6.0mm 24FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483021125 Catalog Number :

Device Description : E/T TUBE NO-CUFF 6.5mm 26FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483021132 Catalog Number :

Device Description : E/T TUBE NO-CUFF 7.0mm 28FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483021583 Catalog Number :

Device Description : Foley Latex 3 Way 30cc 28fr

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034002 Catalog Number :

Device Description : ENDOBRONCHIAL ROBERTSHAW RIGHT 35FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034019 Catalog Number :

Device Description : ENDOBRONCHIAL ROBERTSHAW RIGHT 37FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034026 Catalog Number :

Device Description : ENDOBRONCHIAL ROBERTSHAW RIGHT 39FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034033 Catalog Number :

Device Description : ENDOBRONCHIAL ROBERTSHAW RIGHT 41FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034040 Catalog Number :

Device Description : PREFORMED ORAL UNCUFFED E/T TUBE 3mm 12FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483034057 Catalog Number :

Device Description : PREFORMED ORAL UNCUFFED E/T TUBE 3.5mm 14FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

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