DM2 B

Basic Information

• Brand Name: DM2 B
• Primary DI: 05414904005026
• Version / Model: DM 2 B 35x43
• Catalog Number: EP1ND
• Company Name: AGFA
• Labeler DUNS: 374444883
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-11-04
• Public Version: 1
• Public Version Date: 2022-11-14
• Public Version Status: New
• Public Device Record Key: 76827500-77ba-4846-b510-546ab1cab6cc

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWZ	Film, radiographic	Radiology	892.1840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63183	Medical printer film	A thin transparent film intended to be used with an appropriate printer to produce a hard copy of a medical image generated by a digital diagnostic radiological system [during, e.g., angiography, magnetic resonance imaging (MRI), nuclear medicine, ultrasound (US), computed tomography (CT)]; it is not photographically light sensitive. It is intended to assist high-quality diagnostic evaluation and is used as a hard-copy alternative to, e.g., medical printer paper or photographically sensitive x-ray film. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05414904224786	GS1		5	In Commercial Distribution
Primary	05414904005026	GS1
Unit of Use	05414904224779	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	43	Centimeter
Length	35	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h).
• Type: Handling Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius