FDA.report

Drive

Primary DI
10822383584239
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
BP3200
Device description
BP Monitor, Deluxe, Auto,Wrist, 1/EA
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10822383584239PackageGS124In Commercial Distribution
00822383584232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1082238358423910822383584239
00822383584232008223835842328223835842320822383584232

GMDN Terms

TermDefinition
Noninvasive haemodynamic monitoring systemAn assembly of mains electricity (AC-powered) devices intended to be used for the noninvasive continuous measurement of arterial blood pressure, cardiac output, and other haemodynamic variables by automated radial arterial tonometry. It consists of a bracelet-like detection device worn on the wrist and an attached monitor with user interface. It is typically used in the operating arena or the intensive care unit (ICU).

Sterilization Methods

Method

Regulatory Flags

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

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