FDA.report

BV Medical

Primary DI
00845821022158
Brand
BV Medical
Company
BV Medical
Model
60-402-000-1
Device description
Penlights, Disposable, With Pupil Gauge, Single
Published
2018-09-03
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
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications

CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845821022158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845821022158008458210221588458210221580845821022158

GMDN Terms

TermDefinition
Hand-held examination/treatment lightA small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. 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
false
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

Primary DIBrandModelCatalogPublished
00845821032737BV Medical 40-208-000-BULK2022-03-31
00845821032478BV Medical20-218-014-AUTISM-L2021-03-12
00845821032485BV Medical20-218-015-AUTISM-L2021-03-12
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
B366LED0204R00PORTALEDEclerisKYT2026-02-11
B366LED0204PORTALEDEclerisKYT2026-01-23
04053755203314DELTA XHeine Optotechnik GmbH & Co. KGKYT2025-12-03
04053755203321DELTA X CPPHeine Optotechnik GmbH & Co. KGKYT2025-12-03
04053755203338DELTA X CPGHeine Optotechnik GmbH & Co. KGKYT2025-12-03
00851289007347FireflyFirefly GlobalKYT2025-07-18
04053755202928DELTAoneHeine Optotechnik GmbH & Co. KGKYT2025-04-30
07465850912003Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912010Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912027Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912034Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912041Dr. VampaDr Vampa S.R.L.KYT2025-03-10
00814005023526RADBL25Quality Aspirators, Inc.KYT2025-02-27
00814005023533RADBLC1Quality Aspirators, Inc.KYT2025-02-27
00814005023540RADFILM5Quality Aspirators, Inc.KYT2025-02-27
00814005023571RADHU2Quality Aspirators, Inc.KYT2025-02-27
00814005023595RADHUM4Quality Aspirators, Inc.KYT2025-02-27
00814005023618RADINST1Quality Aspirators, Inc.KYT2025-02-27
00814005024172RADC25Quality Aspirators, Inc.KYT2025-02-27
00814005024189RADFILM6Quality Aspirators, Inc.KYT2025-02-27
008140050242572 Pin Detachable CableQuality Aspirators, Inc.KYT2025-02-27
00814005024288M-CZQuality Aspirators, Inc.KYT2025-02-27
00814005024295M-ORTTL AssemblyQuality Aspirators, Inc.KYT2025-02-27
00814005024301M-COQuality Aspirators, Inc.KYT2025-02-27
00814005024370M-KEQuality Aspirators, Inc.KYT2025-02-27
00814005024387M-HBQuality Aspirators, Inc.KYT2025-02-27
00814005024394M-ORQuality Aspirators, Inc.KYT2025-02-27
00814005024400M-QFQuality Aspirators, Inc.KYT2025-02-27
00814005024431M-SUQuality Aspirators, Inc.KYT2025-02-27