FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 00643169838499 · Model: 450001-020 · Medtronic Care Management Services, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NA
Primary DI
00643169838499
Version / Model
450001-020
Company Name
Medtronic Care Management Services, LLC
Labeler DUNS
061079989
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-08
Public Version
3
Public Version Date
2019-07-22
Public Version Status
Update
Public Device Record Key
305d4b71-9b62-4d90-b4d1-436b6022ce47

Device Description

BP CUFF REGULAR MEDIUM BP-D02

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
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
Yes
Has Lot/Batch Number
No
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
34978 Blood pressure cuff, reusable

Identifiers

Type ID
Primary 00643169838499

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-4 – 131 Degrees Fahrenheit