FDA.reportPublic FDA data

Good Neighbor

Primary DI
00087701427404
Brand
Good Neighbor
Company
Amerisourcebergen Drug Corporation
Model
90-50D
Device description
Good Neighbor Pharmacy Deluxe Pulse Oximeter
Published
2024-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OCHOximeter, Infrared, Sporting, Aviation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCHOximeter, Infrared, Sporting, AviationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082641000FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLContec Medical System Co., Ltd.2008-11-10DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10087701427401PackageGS124In Commercial Distribution
30087701427405PackageGS13In Commercial Distribution
00087701427404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1008770142740110087701427401
3008770142740530087701427405
00087701427404000877014274040877014274040087701427404

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.

Regulatory Flags#

DUNS number
007914906
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00087701432699Good Neighbor Pharmacy611646102336602025-08-13
00087701432866Good Neighbor Pharmacy611646102336702025-08-13
00087701432910Good Neighbor Pharmacy611646102336802025-08-13
00087701432927Good Neighbor Pharmacy611646102336542025-08-13
00087701190667Good Neighbor PharmacySQN542025-03-03
20087701190661Good Neighbor PharmacySQN542025-03-03
00087701429477Good Neighbor90-3632024-09-26
00087701429484Good Neighbor90-3312024-09-26
30087701429478Good Neighbor90-3632024-09-26
30087701429485Good Neighbor90-3312024-09-26
00087701427411Good Neighbor90-50K2024-09-18
00087701429491Good Neighbor90-3482024-09-18
00087701429989Good Neighbor90-55012024-09-18
00087701430145Good Neighbor90-3102024-09-18
00087701430152Good Neighbor90-5102024-09-18
30087701427405Good Neighbor90-50D2024-09-18
30087701427412Good Neighbor90-50K2024-09-18
30087701429492Good Neighbor90-3482024-09-18
30087701429980Good Neighbor90-55012024-09-18
10087701430142Good Neighbor90-3102024-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979934380042ConcordChangsha Brilliant Easesyn Technology Co.,Ltd.OCH2026-05-26
06979934380059ConcordChangsha Brilliant Easesyn Technology Co.,Ltd.OCH2026-05-26
06938395500321CONCORDShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-28
06938395500314AccuMedShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-27
06938395500284AccuMedShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-15
08719481723408iProvènSevenground Trading B.V.OCH2026-03-09
06973912940525 simplicare IMDKOCH2025-12-03
06951740540377THERMOBIOShenzhen Jumper Medical Equipment Co.,Ltd.OCH2025-10-18
00846841092527ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-09-29
06951740540360NOVAShenzhen Jumper Medical Equipment Co.,Ltd.OCH2025-08-07
00846841091599mibestBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00846841092701mibestBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00846841092947ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00850043916000ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00850043916024ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00850043916031ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00851697006543InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
00851697006659InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007513ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007698ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007704ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007728ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007780ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007803ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007810ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007827ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007919ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007964ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00850000967311CMI HealthCMI HEALTH INC.OCH2025-01-17
06941900601314Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27