FDA.report

Chart, X-Ref Puritan Bennett 4020

Primary DI
00817081025835
Brand
Chart, X-Ref Puritan Bennett 4020
Company
A-M SYSTEMS, LLC
Model
Chart, X-Ref Puritan Bennett 4020 - 141200
Catalog number
141200
Device description
Chart, X-Ref Puritan Bennett 4020, 8.5 x 11, Green
Published
2020-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DSFRecorder, Paper Chart

Product Code Classifications

CodeDeviceSpecialtyClass
DSFRecorder, Paper ChartCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817081025835PackageGS1100In Commercial Distribution
00817081025828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081025835008170810258358170810258350817081025835
00817081025828008170810258288170810258280817081025828

GMDN Terms

TermDefinition
Paper chart recorderA mains electricity (AC-powered) electronic device, which may include internal rechargeable batteries, intended to receive an input signal (e.g., from a physiological amplifier, signal conditioner, computer) which it converts and transcribes onto paper so that the information is stored in the form of a permanent document (hard copy). It will typically include a paper chart driven at constant speed by a motor and a pen(s) that moves back and forth in response to the signal, a printing array (e.g., thermal or electrostatic), or another device for printing on paper. It may be stationary or portable and will typically be used in the absence of a built-in chart recorder.

Sterilization Methods

Method

Contacts

PhoneEmail
3606838300sales@a-msystems.com

Regulatory Flags

DUNS number
020275145
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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