MIN-R EV Film

Basic Information

• Brand Name: MIN-R EV Film
• Primary DI: 40889971687445
• Version / Model: MIN-R EV Film
• Catalog Number: 1687441
• Company Name: CARESTREAM HEALTH, INC.
• Labeler DUNS: 793169512
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a66bfc81-bef0-400c-85db-c360dfaf8584
• Distribution End Date: 2016-09-30

Device Description

MIN-R EV Film 18X24cm 100SH

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
IWZ	Film, radiographic	Radiology	892.1840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40979	Medical x-ray film, screen	A screen x-ray film specifically designed for medical diagnostic imaging applications. It is sensitive primarily to wavelengths of light emitted from an image intensifying screen or other visible light source. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material. This film is not limited to use with x-ray imaging systems but can also be used in a variety of diagnostic imaging modalities using image intensifier technology or matrix formatters to output images, e.g., nuclear medicine or ultrasound.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60889971687449	GS1	Case	5	Not in Commercial Distribution	2016-09-30
Primary	40889971687445	GS1
Unit of Use	00889971687447	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: Low: 30 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: Low: 60 Percent (%) Relative Humidity