FDA.reportPublic FDA data

Greater Goods

Primary DI
10875011000038
Brand
Greater Goods
Company
Greater Goods
Model
0003
Device description
Bluetooth Pulse Oximeter (RPM)
Published
2022-01-18
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

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151206000Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.2015-08-28DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10875011000038PackageGS1100In Commercial Distribution
00875011000031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087501100003810875011000038
00875011000031008750110000318750110000310875011000031

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
189583599
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00875011000406Greater Goods 00402025-06-09
10875011000403Greater Goods 00402025-06-09
00875011000116Greater Goods 00112025-04-20
00875011000123Greater Goods 00122025-04-20
10875011000113Greater Goods 00112025-04-20
10875011000120Greater Goods 00122025-04-20
00875011006675Greater Goods 06672025-02-12
00875011006927Greater Goods 06922025-02-12
00875011006934Greater Goods 06932025-02-12
00875011006941Greater Goods 06942025-02-12
00875011006613Greater Goods 06612025-02-12
10875011006672Greater Goods 06672025-02-12
10875011006924Greater Goods 06922025-02-12
10875011006931Greater Goods 06932025-02-12
10875011006948Greater Goods 06942025-02-12
00875011006699Greater Goods06692024-11-24
00875011006682Greater Goods06682024-11-24
10875011006696Greater Goods06692024-11-24
00875011006125Greater Goods06122020-08-31
00875011006149Greater Goods06142020-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572900APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725572948APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725516812APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516829APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516836APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516843APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516850APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516867APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516874APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516881APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516898APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516904APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516911APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516928APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516935APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516942APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516959APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516966APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516973APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516980APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516997APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517000APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517017APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517024APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517031APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517048APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517055APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517062APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517079APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517086APKAPK Technology Co.,Ltd.DQA2026-03-12