FDA.report

Valhalla Scientific, Inc

Primary DI
B719HT3C0
Brand
Valhalla Scientific, Inc
Company
Valhalla Scientific
Model
G6
Catalog number
HT3C
Published
2024-03-15
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

Product Codes

CodeName
DSBPlethysmograph, Impedance

Product Code Classifications

CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B719HT3C0PrimaryHIBCC0

GMDN Terms

TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Sterilization Methods

Method

Regulatory Flags

DUNS number
056590342
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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
B719G73C0Valhalla Scientific, IncG7G73C2025-07-28
B719G62J0Valhalla Scientific, IncG6G62J2024-06-17
B719G63C0Valhalla Scientific, IncG6G63C2024-04-12
B719BE3B0Valhalla Scientific, IncG6-BCS EliteBE3B2024-03-15
B719G61S0Valhalla Scientific, IncG6G61S2024-03-15
B719G62Q0Valhalla Scientific, IncG6G62Q2024-03-15
B719G62S0Valhalla Scientific, IncG6G62S2024-03-15
B719G63S0Valhalla Scientific, IncG6G63S2024-03-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B719G73C0Valhalla Scientific, IncValhalla ScientificDSB2025-07-28
B719G62J0Valhalla Scientific, IncValhalla ScientificDSB2024-06-17
B719G63C0Valhalla Scientific, IncValhalla ScientificDSB2024-04-12
B719BE3B0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G61S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G62Q0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G62S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G63S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
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00817065022577HokansonD.E.HOKANSON, INC.DSB2020-09-23
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37630039301812Injector Mounting Arm, RightBracco Injeneering SADSB2020-09-17
07290110070281ReDS SystemSENSIBLE MEDICAL INNOVATIONS LTDDSB2020-08-18
07290110070243ReDS Pro SystemSENSIBLE MEDICAL INNOVATIONS LTDDSB2020-07-02
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06944904096780ICG module (w accessory kit)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.DSB2020-05-08
37630039301720EDA Module KitBracco Injeneering SADSB2020-05-05
00817065022515HokansonD.E.HOKANSON, INC.DSB2020-02-20