FDA.reportPublic FDA data

AED

Primary DI
00848657085762
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
EP1000
Device description
AED ENDOPRO-CAM®Portable HD Endoscope Video System
Published
2017-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FENDEVICE, CYSTOMETRIC, HYDRAULIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FENDevice, Cystometric, HydraulicGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657085762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657085762008486570857628486570857620848657085762

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
839138955
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848657078368AEDAED UH8012026-04-23
00848657078276AEDAED 33310UL-R2026-04-13
00848657078283AEDAED 33310UL2026-04-13
00848657078290AEDAED 33321A-R2026-04-13
00848657078306AEDAED 33321A2026-04-13
00848657078313AEDAED 33310FG-R2026-04-13
00848657078320AEDAED 33310FG2026-04-13
00848657078337AEDAED 33310R-R2026-04-13
00848657078344AEDAED 33310R2026-04-13
00848657078351AEDAED 34321SL2026-04-13
00848657078269AEDJZM15922026-03-02
00848657078238AED8830BL2026-02-24
00848657078245AED8830CL2026-02-24
00848657078252AED8830FL2026-02-24
00848657078214AED501.50BS2026-02-18
00848657078221AED501.51BS2026-02-18
00848657023122AEDAED11275FE2026-01-23
00848657023139AEDAED27071TJ2026-01-23
00848657068956AED2717462026-01-23
00848657069236AEDAED27071-92026-01-23

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10627825014868T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
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10627825010402Tubing, Extension Line, 2 Set, Blue/Red, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010419Tubing, Extension Line, 3 Set, Blue/Red/Yellow, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010426Pump Guard / Dampening chamberLaborie Medical Technologies Canada ULCFEN2017-10-01
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10627825010471Catheter, Pabd, Single Lumen, Closed Balloon, Silicone, 12FrLaborie Medical Technologies Canada ULCFEN2017-10-01
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