FDA UDI In Commercial Distribution 🇺🇸 United States

Statcorp Medical

DI: 30841522111024 · Model: STATCORP · Statcorp Medical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Statcorp Medical
Primary DI
30841522111024
Version / Model
STATCORP
Catalog Number
VNN1ST-10
Company Name
Statcorp Medical
Labeler DUNS
602075905
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-19
Public Version
7
Public Version Date
2021-06-09
Public Version Status
Update
Public Device Record Key
4f0b7985-e3e7-4ffc-9628-0c033d9900c1

Device Description

BP CUFF,SC VINYL NEO,1T,SIZE 1,3-6CM,ML,10/BX

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DXQ blood pressure cuff

GMDN Terms

Code Name
37326 Blood pressure cuff, single-use

Identifiers

Type ID
Primary 30841522111024

Premarket Submissions

Submission Number Supplement Number
K940214 000

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-20 – 60 Degrees Celsius
Type
Storage Environment Humidity
Temperature Range
5 – 95 Percent (%) Relative Humidity