FDA.report

PANACARE

Primary DI
06920485308412
Brand
PANACARE
Company
Shenzhen BSX Technology Electronics Co., Ltd.
Model
BSX322
Published
2026-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications

CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions

SubmissionSupplement
K241578000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241578000Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)Shenzhen Bsx Technology Electronics Co., Ltd.2025-02-19DXN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06920485308412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06920485308412069204853084126920485308412

GMDN Terms

TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn 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.

Regulatory Flags

DUNS number
551105453
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06920485307583BSXINBSX3152025-06-30
06920485305015BOTHEALTHBSX5012019-12-14
06920485305053BOTHEALTHBSX5052019-12-14
06920485305084BOTHEALTHBSX5082019-12-14
06920485305138BOTHEALTHBSX5132019-12-14
06920485305152BOTHEALTHBSX5152019-12-14
06920485305190BOTHEALTHBSX5192019-12-14
06920485305268BOTHEALTHBSX5262019-12-14
06920485305381BOTHEALTHBSX5382019-12-14
06920485305534BOTHEALTHBSX5532019-12-14
06920485305565BOTHEALTHBSX5562019-12-14
06920485305589BOTHEALTHBSX5582019-12-14
06920485305619BOTHEALTHBSX5612019-12-14
06920485305633BOTHEALTHBSX5632019-12-14
06920485305688BOTHEALTHBSX5682019-12-14
06920485305725BOTHEALTHBSX5722019-12-14
06920485305787BOTHEALTHBSX5782019-12-14
06920485305794BOTHEALTHBSX5792019-12-14
06920485305879BOTHEALTHBSX5872019-12-14
06920485305237BOTHEALTHBSX5232019-09-20

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