renpho Pulse Oximeter RP-PO001

GUDID 00860002249636

JOICOM CORPORATION

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Primary Device ID	00860002249636
NIH Device Record Key	28832954-af61-4c13-8b56-e68ba4bb46fd
Commercial Distribution Status	In Commercial Distribution
Brand Name	renpho Pulse Oximeter
Version Model Number	RP-PO001
Catalog Number	RP-PO001
Company DUNS	081060692
Company Name	JOICOM CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002249636 [Primary]
GS1	30860002249637 [Package] Package: Carton [100 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141105

FDA Product Code

DQA

Oximeter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-04-09
Device Publish Date	2020-04-01

On-Brand Devices [renpho Pulse Oximeter]

00860002249636	RP-PO001
30850023727009	RP-PO001
50860002249655	R-J002