FDA.report

BV Medical

Primary DI
00845821025401
Brand
BV Medical
Company
BV Medical
Model
60-840-250-L
Device description
Conventional 2.5V Mini Otoscope, Royal Blue, Latex Free
Published
2018-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ERAOtoscope

Product Code Classifications

CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845821025401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845821025401008458210254018458210254010845821025401

GMDN Terms

TermDefinition
Otoscope, directA portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)822-8293info@bvmedical.com

Regulatory Flags

DUNS number
105932508
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
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

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00845821032492BV Medical20-218-013-AUTISM-L2021-03-12
00845821032393BV Medical 40-101-900-L2020-12-16
00845821028327School Health20-218-014-SH-L2016-12-24
00845821032027BV Medical80-700-1902019-09-06
00845821032034BV Medical80-700-2502019-09-06
00845821031990BV Medical80-700-0002019-08-22
00845821010513BV Medical80-172-0002018-09-24
00845821010520BV Medical80-173-0002018-09-24
00845821010537BV Medical80-174-0002018-09-24
00845821010544BV Medical80-174-0102018-09-24
00845821010551BV Medical80-174-0702018-09-24
00845821010568BV Medical80-174-0602018-09-24
00845821010575BV Medical80-174-1302018-09-24
00845821010582BV Medical80-174-2502018-09-24
00845821010599BV Medical80-175-0002018-09-24
00845821010605BV Medical80-176-0002018-09-24
00845821010612BV Medical80-177-0002018-09-24

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