Diagnostix™

Basic Information

• Brand Name: Diagnostix™
• Primary DI: 00634782093907
• Version / Model: 2100CN
• Catalog Number: 2100CN
• Company Name: AMERICAN DIAGNOSTIC CORP
• Labeler DUNS: 108999095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-30
• Public Version: 6
• Public Version Date: 2023-12-29
• Public Version Status: Update
• Public Device Record Key: 55e11ab8-ca86-4cd5-9358-1a5e8776db76

Device Description

DIAGNOSTIX Pulse Oximeter,Fingertip, Adult, Canada only

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45607	Pulse oximeter	An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00634782595326	GS1	Master Case	25	Not in Commercial Distribution	2023-12-29
Package	00634782895327	GS1	Inner pack	10	In Commercial Distribution
Primary	00634782093907	GS1
Package	00634782500221	GS1	Master Case	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K101577	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Finger Thickness .31 to .79 inches.

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity