Stork

Basic Information

• Brand Name: Stork
• Primary DI: 00843997009416
• Version / Model: 95083
• Company Name: MASIMO CORPORATION
• Labeler DUNS: 780421038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-31
• Public Version: 1
• Public Version Date: 2024-11-08
• Public Version Status: New
• Public Device Record Key: aa9281e1-c075-46b8-9cc9-5d0e43c1e217

Device Description

Stork Vitals

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
65834	Wearable multiple vital physiological parameter monitoring system	A portable assembly of electrically-powered devices intended to be worn by a patient in a healthcare or homecare setting for intermittent assessment or continuous monitoring, exclusively by a healthcare professional, of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, haemoglobin oxygen saturation (SpO2), haematocrit]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff, skin patch) and processing hardware with dedicated software. It may include a monitoring screen or allow for remote communication with a smart device or central database.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	00843997017589	GS1
Primary	00843997009416	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K234021	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius