FDA.report

MediChoice

Primary DI
20885632057738
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
CP7988
Device description
Chart Paper Ekg Z-fold 3-channel Red Grid 300/pd 215mm X 140mm Disposable/sngle Use Not Nat Rubber Ltx Non Sterile MediChoice
Published
2020-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DSFRECORDER, PAPER CHART

Product Code Classifications

CodeDeviceSpecialtyClass
DSFRecorder, Paper ChartCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885632057738PackageGS120In Commercial Distribution
10885632057731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088563205773820885632057738
1088563205773110885632057731

GMDN Terms

TermDefinition
Medical printer paperA thin sheet of fibrous material intended to be used to produce a hard copy of printed data/images generated by a medical device (e.g., laboratory instrument/analyser, electrocardiograph, x-ray imaging system, hospital printer). It is typically available as a continuous length of paper (e.g., roll or accordion) or as individual sheets of paper; some types are pre-treated with thermochromic ink for use with thermal printers. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Do not expose to direct sunlight or place into contact with or near carbon paper, carbonless forms, adhesives, adhesive tapes, solvents or plastics such as page protectors, dividers or folders.
Storage Environment Humidity40 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature35 Degrees Fahrenheit100 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
007941230
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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