FDA.report

VS Cap Extra Large

Primary DI
05060550650044
Brand
VS Cap Extra Large
Company
SUREPULSE MEDICAL LIMITED
Model
SP-163-A-1
Device description
VS Cap Extra Large
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DQAOximeter

Product Code Classifications

CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions

SubmissionSupplement
K201887000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K201887000VS Newborn Heart Rate MonitorSurepulse Medical Limited2021-07-23DQA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060550650129PackageGS110In Commercial Distribution
05060550650044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060550650129050605506501295060550650129
05060550650044050605506500445060550650044

GMDN Terms

TermDefinition
Neonatal multi-parameter bedside monitorA device/device assembly designed to continuously measure and display multiple vital physiological parameters of newborn and premature infants, especially those under critical care. It is typically capable of monitoring parameters such as electrocardiogram (ECG), respiration rate, heart rate, blood pressure, and body temperature; it may also assess haemoglobin oxygen saturation (SpO2) through transcutaneous sensors that measure both transcutaneous oxygen (tcPO2) and transcutaneous carbon dioxide (tcPCO2) saturation. The system typically includes sensors with appropriate size and design for infant use.

Sterilization Methods

Method

Regulatory Flags

DUNS number
218453362
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
true
Expiration date on label
true
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 DIBrandModelCatalogPublished
05060550650006VS Cap Extra SmallSP-159-A-12025-06-26
05060550650013VS Cap SmallSP-160-A-12025-06-26
05060550650020VS Cap MediumSP-161-A-12025-06-26
05060550650037VS Cap LargeSP-162-A-12025-06-26
05060550650075VS SystemSP-146-A-12025-06-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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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
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06946725550182APKAPK Technology Co.,Ltd.DQA2026-03-19
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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
06946725550304APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550311APKAPK Technology Co.,Ltd.DQA2026-03-19