PAQ.63X100X300.FUKUDA OP-114TE

Basic Information

• Brand Name: PAQ.63X100X300.FUKUDA OP-114TE
• Primary DI: 08428763008248
• Version / Model: 2906302
• Company Name: AB MEDICA GROUP, S.A.
• Labeler DUNS: 460037021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-23
• Public Version: 1
• Public Version Date: 2025-07-31
• Public Version Status: New
• Public Device Record Key: 0e6876b1-6178-47a4-907e-1ec123370fbe

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

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	08428763008248	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry