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) (8) Ophthalmoscope, Battery-Powered (HLJ) (1) Oximeter (DQA) (1)

Premarket Exempt

Yes No

Clear

Sunmed - 10889483007471 Catalog Number :

Device Description : Diagnostic Kit

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483007532 Catalog Number :

Device Description : SunMed Finger Pulse Oximeter with Case

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483008966 Catalog Number :

Device Description : ENDOBRONCHIAL ROBERTSHAW LEFT 35FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483008973 Catalog Number :

Device Description : ENDOBRONCHIAL ROBERTSHAW LEFT 37FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483008980 Catalog Number :

Device Description : ENDOBRONCHIAL ROBERTSHAW LEFT 39FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483008997 Catalog Number :

Device Description : ENDOBRONCHIAL ROBERTSHAW LEFT 41FR

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483009000 Catalog Number :

Device Description : PREFORMED ORAL 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 - 10889483009017 Catalog Number :

Device Description : PREFORMED ORAL 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 - 10889483009024 Catalog Number :

Device Description : PREFORMED ORAL 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 - 10889483009031 Catalog Number :

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

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

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