FDA.reportPublic FDA data

ERBEFLO CleverCap®

Primary DI
04065655000405
Brand
ERBEFLO CleverCap®
Company
Erbe Medical, LLC
Model
20325-240
Catalog number
20325-240
Device description
Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & UCR
Published
2023-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

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
K162152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162152000Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.2016-08-31FEQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04065655000412PackageGS110In Commercial Distribution
04065655000429PackageGS13In Commercial Distribution
04050147020542PreviousGS10
04065655000405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04065655000412040656550004124065655000412
04065655000429040656550004294065655000429
04050147020542040501470205424050147020542
04065655000405040656550004054065655000405

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional 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
1-770-955-4400technicalservice@erbe-usa.com

Regulatory Flags#

DUNS number
117862528
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04065655001396ERBEFLO®20325-22520325-2252023-10-11
04065655000436ERBEFLO CleverCap®20325-20620325-2062023-09-22
04065655000603ERBEFLO CleverCap®20325-20120325-2012023-09-22
04065655000689ERBEFLO CleverCap®20325-20720325-2072023-09-22
04065655000887ERBEFLO CleverCap®20325-20920325-2092023-09-22
04065655000917ERBEFLO CleverCap®20325-21920325-2192023-09-22
04065655000948ERBEFLO AeroRinse®20325-23520325-2352023-09-22
04065655000979ERBEFLO AeroRinse®20325-24320325-2432023-09-22
04065655001006ERBEFLO CleverCap®20325-24820325-2482023-09-22
04065655001037ERBEFLO AeroRinse®20325-23620325-2362023-09-22
04065655001068ERBEFLO AeroRinse®20325-23720325-2372023-09-22
04065655001099ERBEFLO CleverCap®20325-20820325-2082023-09-22
04065655001150ERBEFLO CleverCap®20325-20220325-2022023-09-22
04065655001211ERBEFLO CleverCap®20325-20320325-2032023-09-22
04065655001242ERBEFLO AeroRinse®20325-23220325-2322023-09-22
04065655001273ERBEFLO AeroRinse®20325-23320325-2332023-09-22
04065655001303ERBEFLO CleverCap®20325-20520325-2052023-09-22
04065655001365ERBEFLO AeroRinse®20325-23120325-2312023-09-22
04065655000375ERBEFLO CleverCap®20325-23920325-2392023-09-22
04065655000825ERBEFLO CleverCap®20325-20620325-2062023-09-22

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
04065655000825ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000863ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000894ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22