FDA.reportPublic FDA data

AED

Primary DI
00848657087094
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
32-4228
Device description
AED RIGID VISUAL OBTURATOR, 24FR
Published
2019-06-14
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

Product Codes#

Code, Name table
CodeName
FAJCystoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657087094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657087094008486570870948486570870940848657087094

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope obturatorAn endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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
00850081334033Zenflow Spring® ScopeZENFLOW, INC.FAJ2026-05-22
00850081334057Zenflow Camera Control UnitZENFLOW, INC.FAJ2026-05-22
00848657023122AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657023139AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657068956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069236AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069243AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069250AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069618AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657074889AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075060AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075084AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075244AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075725AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657076289AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657076692AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078160AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078177AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078184AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078191AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657086936AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657086943AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00810116023431Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-01-22
06971176281729EviewZhuhai Pusen Medical Technology Co, LtdFAJ2026-01-22
06971176281965EviewZhuhai Pusen Medical Technology Co, LtdFAJ2026-01-22
06971176283570Foot Switch (HRF-M5 PS)Zhuhai Pusen Medical Technology Co, LtdFAJ2026-01-22
00848657076845AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-15
00848657077040AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-15
00848657078061AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-15
06972520302893Ascend™ Single-Use Flexible Cysto-Nephroscope HDGuangzhou Red Pine Medical Instrument Co., Ltd.FAJ2025-12-31