FDA.report

Philips body analysis scale

Primary DI
20075020060239
Brand
Philips body analysis scale
Company
Philips Medical Systems Nederland B.V.
Model
DL8781
Device description
DL8781/38 US
Published
2016-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MNWAnalyzer, Body Composition

Product Code Classifications

CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20075020060239PackageGS13In Commercial Distribution
00075020060969PrimaryGS10

GMDN Terms

TermDefinition
Stand-on floor scale, electronicAn electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.

Sterilization Methods

Method

Regulatory Flags

DUNS number
489844773
Device count
1
DM exempt
false
Premarket exempt
true
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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