FDA.reportPublic FDA data

Hopkins

Primary DI
00817643023965
Brand
Hopkins
Company
MARKETLAB INC.
Model
138041
Device description
Replacement Neonate Wrap
Published
2023-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172792000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172792000Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.2018-11-13DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817643023965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817643023965008176430239658176430239650817643023965

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
848917027
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817518024523MarketLab, Inc.1087812025-12-18
00817643023972Hopkins1380422024-02-02
00817517027938Marketlab-Clinton1387632024-02-02
00817517027945Marketlab-Clinton1387642024-02-02
00817517027952Marketlab-Clinton1387652024-02-02
00817517027969Marketlab-Clinton1387662024-02-02
00817517027976Marketlab-Clinton1387672024-02-02
00817517027983Marketlab-Clinton1387682024-02-02
00817517027990Marketlab-Clinton1387692024-02-02
00817517028003Marketlab-Clinton1387702024-02-02
00817517028072Marketlab-Clinton1387712024-02-02
00817517028089Marketlab-Clinton1387722024-02-02
00817517028096Marketlab-Clinton1387732024-02-02
00817517028102Marketlab-Clinton1387742024-02-02
00817517028119Marketlab-Clinton1387752024-02-02
00817517028126Marketlab-Clinton1387762024-02-02
00817517028133Marketlab-Clinton1387772024-02-02
00817517028140Marketlab-Clinton1387782024-02-02
00817517028157Marketlab-Clinton1387792024-02-02
00817517028164Marketlab-Clinton1387802024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09