Erbe Medical, LLC

Address:405 W Geneva Dr,Tempe,AZ,85282,US

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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

Endoscopic Irrigation/Suction System (OCX) (9)

Premarket Exempt

Clear

ERBEFLO® 2 - 04065655000108 Catalog Number : 20325-211

Device Description : Endoscopy Port Connector for Olympus® Scopes

Device Class : 2

Duns Number: 117862528

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ERBEFLO® 2 - 04065655000139 Catalog Number : 20325-215

Device Description : Endo. Port Connector w/Valve for Olympus® Scopes

Device Class : 2

Duns Number: 117862528

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ERBEFLO® 2 - 04065655000160 Catalog Number : 20325-212

Device Description : Endoscopy Port Connector for Pentax® Scopes

Device Class : 2

Duns Number: 117862528

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ERBEFLO® 2 - 04065655000191 Catalog Number : 20325-214

Device Description : Back Flow Valve

Device Class :

Duns Number: 117862528

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ERBEFLO® 2 - 04065655000221 Catalog Number : 20325-218

Device Description : Endo Quick Connect Pentax® Scope Port Connector

Device Class : 2

Duns Number: 117862528

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ERBEFLO® 2 - 04065655000252 Catalog Number : 20325-222

Device Description : Endoscopy Pump Tubing/Cap Set

Device Class : 2

Duns Number: 117862528

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ERBEFLO® 2 - 04065655000283 Catalog Number : 20325-223

Device Description : Endoscopy Pump Tubing/ Cap Set for Fujinon® Scopes

Device Class : 2

Duns Number: 117862528

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ERBEFLO® 2 - 04065655000313 Catalog Number : 20325-224

Device Description : Endoscopy OFP & EndoStat Pump Tubing/Cap Set

Device Class : 2

Duns Number: 117862528

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ERBEFLO® 2 - 04065655000344 Catalog Number : 20325-213

Device Description : Endoscopy Channel Adapter

Device Class : 2

Duns Number: 117862528

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

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