FDA.report

AED

Primary DI
00848657087445
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
8840A-XS
Device description
AED OTOSCOPE W/ SHEATH
Published
2019-05-28
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

Related Records

Product Codes

CodeName
ERAOTOSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848657087445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657087445008486570874458486570874450848657087445

GMDN Terms

TermDefinition
Otoscope, endoscopicAn endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.

Sterilization Methods

Method

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
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 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 DIBrandCompanyProduct codePublished
00732094055245Welch Allyn, Inc.WELCH ALLYN, INC.ERA2026-03-06
40050428029495CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
06972545090416JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-02-04
16972545090093JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-02-04
06974546524372TealmedNingbo Tealmed Emergency Products Co., Ltd.ERA2026-01-16
00850042909218ProsidioProsidio LLCERA2025-12-05
00850042909225ProsidioProsidio LLCERA2025-12-05
00850042909256ProsidioProsidio LLCERA2025-12-05
00850042909263ProsidioProsidio LLCERA2025-12-05
00850042909270ProsidioProsidio LLCERA2025-12-05
00850042909287ProsidioProsidio LLCERA2025-12-05
00850042909294ProsidioProsidio LLCERA2025-12-05
00850042909300ProsidioProsidio LLCERA2025-12-05
00850042909317ProsidioProsidio LLCERA2025-12-05
00850042909324ProsidioProsidio LLCERA2025-12-05
00850042909331ProsidioProsidio LLCERA2025-12-05
00850042909348ProsidioProsidio LLCERA2025-12-05
00850042909355ProsidioProsidio LLCERA2025-12-05
00850042909362ProsidioProsidio LLCERA2025-12-05
00850042909379ProsidioProsidio LLCERA2025-12-05
00850042909386ProsidioProsidio LLCERA2025-12-05
00850042909393ProsidioProsidio LLCERA2025-12-05
00850042909409ProsidioProsidio LLCERA2025-12-05
00850042909416ProsidioProsidio LLCERA2025-12-05
00850042909423ProsidioProsidio LLCERA2025-12-05
00850042909430ProsidioProsidio LLCERA2025-12-05
00850042909447ProsidioProsidio LLCERA2025-12-05
00850042909454ProsidioProsidio LLCERA2025-12-05
00850042909461ProsidioProsidio LLCERA2025-12-05
00850042909478ProsidioProsidio LLCERA2025-12-05