Wireless Pulse Oximeter

GUDID 00867661000349

CLOUD DX INC.

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Primary Device ID00867661000349
NIH Device Record Keyc9872588-6186-47b1-80c2-ab92a1c37b5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameWireless Pulse Oximeter
Version Model NumberWPO-10
Company DUNS079659378
Company NameCLOUD DX INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com
Phone888-543-0944
Emailregulatory@CloudDX.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100867661000349 [Primary]

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-26
Device Publish Date2019-09-18

On-Brand Devices [Wireless Pulse Oximeter]

00867661000349WPO-10
00867661000356WPO-10B

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