Tracoe medical GmbH

Address:REICHELSHEIMER STR. 1/3,NIEDER-OLM Rhineland-Palatinate,DE

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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 tracheostomy and tube cuff (JOH) (9) APPLICATOR, ABSORBENT TIPPED, NON-STERILE (KXF) (1)

Premarket Exempt

No Yes

Clear

TRACOE® twist - 04035324056514 Catalog Number :

Device Description : Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324056613 Catalog Number :

Device Description : Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324056712 Catalog Number :

Device Description : Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324056811 Catalog Number :

Device Description : Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324056910 Catalog Number :

Device Description : Tracheostomy Tube, with Low Pressure Cuff and Air Supply Line for Speaking

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324058419 Catalog Number :

Device Description : Inner Cannulas, Fenestrated, with Grooved Low Profile Connector (light blue), 3 units

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324058518 Catalog Number :

Device Description : Spare Inner Cannulas, with 15 mm Connector, 3 units

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324058617 Catalog Number :

Device Description : Spare Inner Cannulas, with 15 mm Connector, 3 units

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324058716 Catalog Number :

Device Description : Spare Inner Cannulas, Fenestrated, with 15 mm Connector (light blue), 3 units

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® care - 04035324059812 Catalog Number :

Device Description : TRACOE tube clean Cleaning swabs large

Device Class : 1

Duns Number: 319414785

Premarket Exempt : Yes

Product Code : KXF

Prescription Use : Yes

Device Count : 1

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