Tracoe medical GmbH

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

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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 tracheostomy and tube cuff (JOH) (6) Dressing,wound,occlusive (NAD) (3) APPLICATOR, ABSORBENT TIPPED, NON-STERILE (KXF) (1)

Premarket Exempt

No Yes

Clear

TRACOE® care - 04035324059911 Catalog Number :

Device Description : TRACOE tube clean Cleaning swabs small

Device Class : 1

Duns Number: 319414785

Premarket Exempt : Yes

Product Code : KXF

Prescription Use : Yes

Device Count : 1

TRACOE® care - 04035324061211 Catalog Number :

Device Description : Tracheal Compresses without slit

Device Class : 1

Duns Number: 319414785

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

TRACOE® care - 04035324061310 Catalog Number :

Device Description : Tracheal Compresses with zigzag slit

Device Class : 1

Duns Number: 319414785

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

TRACOE® twist - 04035324063215 Catalog Number :

Device Description : Tracheostomy Tube with Low Pressure Cuff

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324063314 Catalog Number :

Device Description : Tracheostomy Tube, Fenestrated, with Low Pressure Cuff

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324063413 Catalog Number :

Device Description : Tracheostomy Tube

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324063512 Catalog Number :

Device Description : Tracheostomy Tube, Fenestrated

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324063611 Catalog Number :

Device Description : Laryngectomy Tube

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® twist - 04035324063710 Catalog Number :

Device Description : Tracheostomy Tube, with Low Pressure Cuff and Subglottic Suction Line

Device Class : 2

Duns Number: 319414785

Premarket Exempt : No

Product Code : JOH

Prescription Use : Yes

Device Count : 1

TRACOE® care - 04035324063819 Catalog Number :

Device Description : Two-Ply Tracheal compresses without slit

Device Class : 1

Duns Number: 319414785

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

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