FDA.report

skinPure

Primary DI
00841983104138
Brand
skinPure
Company
NIHON KOHDEN CORPORATION
Model
A/SKINPURE-SAMPLE
Catalog number
A/SKINPURE-SAMPLE
Device description
SKINPURE, 1 SAMPLE TUBE (SKIN PREPARATION GEL)
Published
2017-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GYBMEDIA, ELECTROCONDUCTIVE

Product Code Classifications

CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841983104138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983104138008419831041388419831041380841983104138

GMDN Terms

TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)325-0283info@nkusa.com

Regulatory Flags

DUNS number
690568050
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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