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Boppli

FDA UDI

Class II (US FDA UDI)

by Pyrames, Inc.

Identity

Trade Name
Boppli FDA UDI
Generic Name
Blood glucose/blood pressure monitoring system, point-of-care FDA UDI
Device Name
Boppli Blood Pressure Monitor - Sensor Band - Pouch FDA UDI
Model / Reference
51-0007 FDA UDI
Description
Boppli Blood Pressure Monitor - Sensor Band - Pouch FDA UDI

Identifiers

Primary DI / UDI-DI
00860007282911 FDA UDI
510(k) Number
K223873 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Blood glucose/blood pressure monitoring system, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Blood glucose/blood pressure monitoring system, point-of-care

Boppli by Pyrames, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood glucose/blood pressure monitoring system, point-of-care.

Cleared under the same submission

K223873 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pyrames, Inc.

Sources (1)

  • FDA UDI be648cf8-455f-40ff-a609-848dafa8a9e8 35 fields · synced Jun 8, 2026