FDA.report

BV Medical

Primary DI
00845821028457
Brand
BV Medical
Company
BV Medical
Model
41-009-000
Device description
Probe Covers 100 per Box
Published
2017-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845821028440PackageGS110In Commercial Distribution
00845821028457PackageGS1200In Commercial Distribution
00845821007407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845821028440008458210284408458210284400845821028440
00845821028457008458210284578458210284570845821028457
00845821007407008458210074078458210074070845821007407

GMDN Terms

TermDefinition
Electronic thermometer probe coverA device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use 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
false
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

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