FDA UDI In Commercial Distribution 🇺🇸 United States

Amazon Basic Care

DI: 00195515047968 · Model: B095S3WFGQB · AMAZON.COM SERVICES LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Amazon Basic Care
Primary DI
00195515047968
Version / Model
B095S3WFGQB
Company Name
AMAZON.COM SERVICES LLC
Labeler DUNS
128990418
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-12-21
Public Version
1
Public Version Date
2023-12-29
Public Version Status
New
Public Device Record Key
133c3f74-2686-477b-a6ba-f2335bf8d657

Device Description

Amazon Basic Care Blood Pressure Monitor Wide Range Arm Cuff

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DXN System, Measurement, Blood-Pressure, Non-Invasive

GMDN Terms

Code Name
45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Identifiers

Type ID
Package 10195515047965
Primary 00195515047968