FDA.reportPublic FDA data

SpO2 Sensor

Primary DI
00848530105327
Brand
SpO2 Sensor
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RES7200
Device description
Sunset SPO2 Sensor - Neonatal/Adult (40 kg) 1.5ft cord (Similar to Masimo 2329) NON-replaceable
Published
2025-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070371000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070371000FINGERTIP PULSE OXIMETER MD300CBeijing Choice Electronic Technololgy Co., Ltd.2007-08-13DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530105327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530105327008485301053278485301053270848530105327

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

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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00848530086992Personal Device HolderCSBML6-Hardshell2024-06-28
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00848530080150Comfort Shoulder Bag for B/M6 CylindersCSBM6CSBM62018-07-31
00848530080167Backpack for B/M6, C/M9 or Smaller CylindersCSBM6BPCSBM6BP2018-07-31
00848530080174Comfort Shoulder Bag for C/M9 CylindersCSBM9CSBM92018-07-31
00848530081942Flex O2 BagCSBM6FlexCSBM6Flex2018-07-31
00848530087173Backpack for D CylindersCSBDBPCSBDBP2018-07-31
00848530087784Cylinder Roller Bag & Backpack — Single D/E TankCSBD1RollerCSBD1Roller2018-07-31
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