Paper

Basic Information

• Brand Name: Paper
• Primary DI: 10884838001166
• Version / Model: Thermal Array Recorder Paper, 10 RL
• Catalog Number: 40477A
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-07-19
• Public Version: 5
• Public Version Date: 2022-12-06
• Public Version Status: Update
• Public Device Record Key: c05917dd-6a93-4ca6-8e9a-4bdfc1a7a882

Device Description

10 Rolls Thermal Array Recorder Paper

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
DSF	RECORDER, PAPER CHART	Cardiovascular	870.2810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16754	Electrocardiographic recording paper	A device prepared from a thin sheet of fibrous material, typically with preprinted graphics and designed for recording the output of an electrocardiograph (ECG), or other device, in the form of measured physiologic parameters as an electrocardiogram (ECG). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884838001166	GS1
Unit of Use	00884838001169	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity