FDA.reportPublic FDA data

ERBE

Primary DI
04050147013551
Brand
ERBE
Company
Erbe Elektromedizin GmbH
Model
20325-301
Catalog number
20325-301
Device description
Hybrid Tubing/Cap Set for Olympus® Scopes
Published
2016-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEQPUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103696000ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPESErbe USA, Inc.2011-03-22FEQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050147013551PackageGS17In Commercial Distribution
04050147013568PackageGS15In Commercial Distribution
04050147022003PackageGS110In Commercial Distribution
04050147022010PackageGS13In Commercial Distribution
04050147012981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050147013551040501470135514050147013551
04050147013568040501470135684050147013568
04050147022003040501470220034050147022003
04050147022010040501470220104050147022010
04050147012981040501470129814050147012981

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of sterile flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source for insufflation during an endoscopic (including laparoscopic, arthroscopic) procedure. It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.5Meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat and direct sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4970717550info@erbe-med.com

Regulatory Flags#

DUNS number
316116623
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050147024694Erbe20402-5012026-05-26
04050147023826Erbe20150-12020150-1202026-04-01
04050147023741Erbe10160-0102025-11-03
04050147023161Erbe20180-1002025-10-27
04050147023468Erbe20180-1012025-10-27
04050147023710Erbe20180-1102025-10-14
04050147022959Erbe20150-1112025-10-01
04050147022942Erbe20150-1102025-09-30
04050147023918Erbe20132-32520132-2572025-08-01
04050147023925Erbe20132-32520132-2572025-08-01
04050147024533Erbe20132-25720132-2572025-05-20
04050147024540Erbe20132-25720132-2572025-05-20
04050147017764ERBE20132-25020132-2502019-04-24
04050147017788ERBE20132-25620132-2562019-04-24
04050147018143ERBE20132-25120132-2512019-04-24
04050147018150ERBE20132-25220132-2522019-04-24
04050147018167ERBE20132-25320132-2532019-04-24
04050147018174ERBE20132-25420132-2542019-04-24
04050147024403Erbe20132-25020132-2502025-04-29
04050147024434Erbe20132-25120132-2512025-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.FEQ2025-10-10
00191506038885HydraBOSTON SCIENTIFIC CORPORATIONFEQ2024-10-07
00191506038892HydraBOSTON SCIENTIFIC CORPORATIONFEQ2024-10-07
M710TCW101200Bayou™ troCarWash System Disposable KitBIOTEX, INC.FEQ2024-01-31
M710TCWC0Bayou™ troCarWash System ControllerBIOTEX, INC.FEQ2024-01-22
00724995228903DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228910DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228927DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228934DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228941DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228958DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228965DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228908DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228922DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228946DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995227340NAUS EndoscopyFEQ2023-11-13
04065655000436ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000689ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000887ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000917ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000948ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655000979ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001006ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655001037ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001068ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001099ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000375ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000405ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000825ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000863ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22