FDA.reportPublic FDA data

AED 25MM Optical Coupler

Primary DI
00848657084772
Brand
AED 25MM Optical Coupler
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
CPL 25
Catalog number
CPL 25
Device description
Optical Coupler: The device is designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. This is a reusable device.
Published
2020-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657084772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657084772008486570847728486570847720848657084772

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope camera adaptorA device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
8182272720customerservice@aed.md

Regulatory Flags#

DUNS number
839138955
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848657078269AEDJZM15922026-03-02
00848657078214AED501.50BS2026-02-18
00848657078221AED501.51BS2026-02-18
00848657023122AEDAED11275FE2026-01-23
00848657023139AEDAED27071TJ2026-01-23
00848657068956AED2717462026-01-23
00848657069236AEDAED27071-92026-01-23
00848657069243AED67161D2026-01-23
00848657069250AED67161FZ2026-01-23
00848657069618AEDA24136-472026-01-23
00848657074889AED2717452026-01-23
00848657075060AED020-017-2200H2026-01-23
00848657075084AED27174T2026-01-23
00848657075244AED2717432026-01-23
00848657075725AEDAED27425ZG2026-01-23
00848657076289AEDAED27023FG2026-01-23
00848657076692AEDA24131-472026-01-23
00848657078160AEDAED27023ZE2026-01-23
00848657078177AEDAED 27174P2026-01-23
00848657078184AEDA24126-472026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810004820463Light Cable, ACMI-ACMI, 1mmCLARUS MEDICAL, LLCFEM2024-12-30
00810004820128Light Cable, ACMI-Wolf/Dyonics, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820135Light Cable, ACMI-Olympus, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820142Light Cable, ACMI-Storz, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820708Adapter, ACMICLARUS MEDICAL, LLCFEM2024-12-23
00810004820715Adapter, OlympusCLARUS MEDICAL, LLCFEM2024-12-23
00810004820722Adapter, StorzCLARUS MEDICAL, LLCFEM2024-12-23
00810004820739Adapter, Wolf/DyonicsCLARUS MEDICAL, LLCFEM2024-12-23
00810004820753Universal Light CableCLARUS MEDICAL, LLCFEM2024-12-23
04055207001189NARichard Wolf GmbHFEM2024-08-06
04055207025024RIWOMOBILRichard Wolf GmbHFEM2024-08-06
04055207008928NARichard Wolf GmbHFEM2024-05-21
04055207009086NARichard Wolf GmbHFEM2024-05-21
04055207009116NARichard Wolf GmbHFEM2024-05-21
08800182600041ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600195ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600331ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600355ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
06972197480887PylonHunan Vathin Medical Instrument Co., LtdFEM2023-10-31
06972197480894TrolleyHunan Vathin Medical Instrument Co., LtdFEM2023-10-31
06972197480900Trolley with pylonHunan Vathin Medical Instrument Co., LtdFEM2023-10-31
00848657023108AED Power Bank Battery, RechargeableNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FEM2023-10-12
00848657023115AED ENDOPRO-CAM® ELITE Camera StandNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FEM2023-10-09
04961333078004PENTAXHOYA CORPORATIONFEM2023-07-31
04961333082308PENTAXHOYA CORPORATIONFEM2023-07-31
04961333082315PENTAXHOYA CORPORATIONFEM2023-07-31
00860009975187Endocraft LLCEndocraft, LLCFEM2023-07-21
00860009975194Endocraft LLCEndocraft, LLCFEM2023-07-21
05019778005228OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFEM2023-06-21
05019778007246OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFEM2023-06-21