Model: C02
DI: 06927709404462
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-25
Current Version: 2026-05-04
Distribution End: 2031-04-24
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e11f1111-7c8a-487e-9c70-9007f57f4206
Distribution Status:
In Commercial Distribution
DUNS Number:
421350239
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
16927709404469
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
48
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06927709404462
Item #1 - Pkg Discontinue Date:
2031-04-24
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06927709404462
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 45617
Name: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Definition:
An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.
FDA Product Codes
DXN
System, Measurement, Blood-Pressure, Non-Invasive
Premarket Submissions
Submission Number:
K200437
Supplement Number:
000