FDA.reportPublic FDA data

Silvercrest

Primary DI
14056232708224
Brand
Silvercrest
Company
LIDL US, LLC
Model
IAN 326857_1901
Catalog number
453.75
Device description
Pulse Oximeter intended for wellness use in measuring the blood oxygen saturation and the heart rate (pulse rate).
Published
2019-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
14056232708224PackageGS14In Commercial Distribution
04056232708227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405623270822414056232708224
04056232708227040562327082274056232708227

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079389709
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055332060105SilvercrestIAN: 391892_2201656.892022-11-20
14055332060102SilvercrestIAN: 391892_2201656.892022-11-20
04056489267393Tampons by LidlBLIXC362021-02-28
04056489466642Tampons by LidlBLIGR362021-05-29
04056489466659Tampons by LidlBLIGS362021-02-28
04056232708227SilvercrestIAN 326857_1901453.752019-08-19
04055334330404SilvercrestIAN 387871_2101454.122021-08-30
04055334351188SilvercrestSWKK60A1238.192021-10-31
04055334351195SilvercrestSKH60A1238.202021-10-31
04055334216562SilvercrestSSHK60E5 (Grey)218.632021-10-31
04055334216579SilvercrestSSHK60E5 (Beige)218.632021-10-31
14055334351185SilvercrestSWKK60A1238.192021-10-31
14055334351192SilvercrestSKH60A1238.202021-10-31
04055334329453SilvercrestIAN 366721_2101 - SBF77 Black760.622021-10-08
04055334329460SilvercrestIAN 366721_2101 - SBF77 White760.632021-10-08
04055334330084SilvercrestIAN 387870_2101793.992021-08-30
04055334329484SilvercrestIAN: 366723_2101653.182021-06-30
07290016625110Tampons by LidlBLIGR362021-02-28
14056489267390Tampons by LidlBLIXC362021-02-28
14056489466656Tampons by LidlBLIGS362021-02-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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