FDA.reportPublic FDA data

ERBEFLO CleverCap®

Primary DI
04065655001105
Brand
ERBEFLO CleverCap®
Company
Erbe Medical, LLC
Model
20325-208
Catalog number
20325-208
Device description
Hybrid CO2 Tubing/Cap Set for Fujinon® Scopes
Published
2023-09-22
Public version status
New
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
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
04065655001105PackageGS110In Commercial Distribution
04065655001143PackageGS13In Commercial Distribution
04050147012837PreviousGS10
04065655001099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04065655001105040656550011054065655001105
04065655001143040656550011434065655001143
04050147012837040501470128374050147012837
04065655001099040656550010994065655001099

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
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
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
04065655000405ERBEFLO CleverCap®20325-24020325-2402023-09-22

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
04065655000405ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000825ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000863ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22