FDA.report

BV Medical

Primary DI
00845821029669
Brand
BV Medical
Company
BV Medical
Model
80-800-000-L
Device description
12" X 24" Heating Pad with three heat settings, No Auto Shut Off
Published
2017-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IRTPad, Heating, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845821029669PackageGS112In Commercial Distribution
00845821027313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845821029669008458210296698458210296690845821029669
00845821027313008458210273138458210273130845821027313

GMDN Terms

TermDefinition
Electric pad whole-body heating systemAn assembly of mains electricity (AC-powered) devices designed to heat a patient's whole body, to compensate for the loss of normal body heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables. The system includes the pad designed to heat under or over the patient, and a control unit to regulate and monitor the heat. The pads are available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). The system is typically used in the operating room (OR), the intensive care unit (ICU), or in neonatal and recovery units.

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

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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