FDA.reportPublic FDA data

OxiWear

Primary DI
00860008683236
Brand
OxiWear
Company
OXIWEAR, INC.
Model
OxiV3
Catalog number
M-001-01
Device description
OxiWear Device and Charger Bundle - Medical - Package of 1
Published
2025-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K233827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233827000OxiWearOxiwear, Inc.2024-08-28DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860008683233PackageGS125In Commercial Distribution
20860008683230PackageGS150In Commercial Distribution
00860008683236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000868323310860008683233
2086000868323020860008683230
00860008683236008600086832368600086832360860008683236

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple physiological parameter recorder, reusableAn electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117449472
Device count
1
DM exempt
false
Premarket exempt
false
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521091986NellcorCovidien LPDQA2026-05-25
06946725571460APKAPK Technology Co.,Ltd.DQA2026-05-22
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549933APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549940APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550021APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550038APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550045APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550069APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550076APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550083APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550090APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550106APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550113APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550137APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550144APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550151APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550168APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550182APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550199APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550205APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550212APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550229APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550236APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550243APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550250APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550267APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550274APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550281APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550298APKAPK Technology Co.,Ltd.DQA2026-03-19