FDA.reportPublic FDA data

Beurer

Primary DI
00810110200135
Brand
Beurer
Company
BEURER NORTH AMERICA, L.P.
Model
PO13
Catalog number
101.53
Device description
Kids Pulse Oximeter
Published
2023-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGJOximeter, Wellness

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGJOximeter, WellnessCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810110200132PackageGS14In Commercial Distribution
20810110200139PackageGS14In Commercial Distribution
00810110200135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011020013210810110200132
2081011020013920810110200139
00810110200135008101102001358101102001350810110200135

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Contacts#

Phone, Email table
PhoneEmail
1-800-536-0366info@beurer.com

Regulatory Flags#

DUNS number
078497467
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003500164BeurerFM250649.472019-06-28
00850003500041BeurerIL51 Art.- No. 619.732019-03-04
00852547004108BeurerIL50 2016-09-24
00850003500478BeurerOT80792.972021-10-01
00810110200159BeurerBM69101.352023-11-07
10810110200156BeurerBM69101.352023-11-07
00853879007515BeurerPREMIUM 800W101.732023-10-23
10853879007512BeurerPREMIUM 800W101.732023-10-23
00810110200111BeurerAuto 400101.082023-10-20
00810110200128BeurerDeluxe 600101.072023-10-20
00810110200166BeurerPREMIUM 800101.552023-10-20
00810110200210BeurerEM29642.312023-10-20
00850018808705BeurerEM 49662.782023-10-20
00850018808910BeurerBM27651.992023-10-20
10810110200118BeurerAuto 400101.082023-10-20
10810110200125BeurerDeluxe 600101.072023-10-20
10810110200163BeurerPREMIUM 800101.552023-10-20
10810110200217BeurerEM29642.312023-10-20
10850018808702BeurerEM 49662.782023-10-20
10850018808917BeurerBM27651.992023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06938395500307HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-04-22
00786585793505SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601921MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601938MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601945MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601952MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392211213MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392211244SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392218793MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392218724SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-27
06938395500253HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-03-13
00050428168721CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2025-09-30
00050428168738CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2025-09-30
00846841092695ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-09-24
B635BIOKIT0100Biokit O2BIOTRICITY INCPGJ2025-09-24
00845717010139Veridian HealthcareVERIDIAN HEALTHCARE LLCPGJ2025-09-09
30845717010130Veridian HealthcareVERIDIAN HEALTHCARE LLCPGJ2025-09-09
00845717011945R.P.M. PROVERIDIAN HEALTHCARE LLCPGJ2025-09-08
00845717012164TrackstarVERIDIAN HEALTHCARE LLCPGJ2025-09-08
00846841092565ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-07-22
00846841092954ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-07-22
06942820462498ChoicemmedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-04-27
00850000967014CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967038CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967052CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967311CMI HealthCMI HEALTH INC.PGJ2025-01-17
06941900601406Pulse OximeterShenzhen Creative Industry Co., Ltd.PGJ2024-12-27
06941900603394Pulse OximeterShenzhen Creative Industry Co., Ltd.PGJ2024-12-27