FDA.reportPublic FDA data

Chart Paper, Thermal, for Cosmed Pony FX Spirometer

Primary DI
00817081025699
Brand
Chart Paper, Thermal, for Cosmed Pony FX Spirometer
Company
A-M SYSTEMS, LLC
Model
Chart Paper, Thermal - 140600
Catalog number
140600
Device description
Chart Paper, Thermal, for Cosmed Pony FX Spirometer
Published
2020-03-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSFRecorder, Paper Chart

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSFRecorder, Paper ChartCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817081025699PackageGS110In Commercial Distribution
00817081025682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081025699008170810256998170810256990817081025699
00817081025682008170810256828170810256820817081025682

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817081028553VBMax28s, PF Testing Filter Labeled DR BurtonVBMax28s, DR Burton - VBMax28s1369042025-08-07
00817081028577VBMax28e, PF Testing Filter Labeled DR BurtonVBMax28e, DR Burton - VBMax28e1469042025-08-07
00817081028515VBMAX34, DISPOSABLE PF TESTING FILTERVBMAX34 - 1564002025-06-25
00817081028539PFT KIT J, VBMax34S w/ Blue Rubber Nose clipPFT KIT J, VBMax34S - 1871741871742025-06-25
00817081028492VBMax34, PF Testing Filter Labeled DR BurtonVBMax34, PF Testing Filter - 1564041564042025-06-03
00817081028478PFT Kit B, VBMax35PFT Kit B, VBMax35 - 1801141801142025-05-12
00817081028454PFT Kit J, VBMax31SPFT Kit J, VBMax31S - 1871411871412025-05-02
00817081028416VBMax28, PF Testing FilterVBMax28, PF Testing Filter - 1569041569042025-04-03
00817081028430PFT Kit B, VBMax35 w/ Blue Foam Nose clipPFT Kit B, VBMax35 - 1801151801152025-04-03
00817081028393PFT Kit I, VBMax36S w/ Foam Nose Clip and 164900PFT Kit I, VBMax36S - 1872661872662025-04-02
00817081028379PFT Kit B, VBMax48PFT Kit B, VBMax48 - 1881021881022025-03-24
00817081028355Pulmonary Function Test Kit EPulmonary Function Test Kit E - 1891241891242025-02-28
00817081028270PFT Kit E, VBMax36E PFT Kit E, VBMax36E - 1891391891392025-02-25
00817081028294Disposable White PFT Nose Clip with Rubber Pads, Labeled D R BurtonDisposable White PFT Nose Clip with Rubber Pads - 1660042025-02-25
00817081028317Disposable Blue PFT Nose Clip with Rubber PadsDisposable Blue PFT Nose Clip - 1667041667042025-02-25
00817081028331Disposable Blue PFT Nose Clip with Foam PadsDisposable Blue PFT Nose Clip with Foam Pads - 1661669042025-02-25
00817081028232Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleDisposable Mouthpiece, Bite Block Style - 1649041649042025-02-21
00817081028256Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingBreathebite Mouthpiece - 1649541649542025-02-21
00817081028218PFT Nose Clip with Foam PadsPFT Nose Clip with Foam Pads1665042025-02-20
00817081028195Pulmonary Function Test Kit EPFT Kit E - 1891251891252025-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08428763008309PAQ. 80x90x280/QT-HS75/ GE MAC400AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008330PAQ.90X70X400*31*OTE.P-80.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008347PAQ.90X90X400*31*SCH.AT1.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008354PAQ.90X90X200*31*SCH.AT4.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008361PAQ.90X90X360*28*MICROSMART.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008385PAQ.90X90X360.MICROSMART.(MX)AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008392PAQ.90X90X130/QT-HS/ZOLLAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008415PAQ.104X100X300*31*CRDT-31.MNAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008439PAQ.106X140X200*31*BURD7971MNAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008446PAQ.108X140X200.ELI-150AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008453PAQ.110X100X300*31*NK.BL.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008460PAQ.110X150X300*31*FQW1103150AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008477PAQ.110X100X200*31*BIOSET3700AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008484PAQ.110X140X150.FQW110-2-140AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008491PAQ.110X150X200.FQW110-3-150AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008507PAQ.110X140X150.FQW1102140.MMAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008514PAQ.110X140X100.FUKUDA FX7202AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008521PAQ.110X150X300.MEDTRONIC9790AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008538PAQ.110X100X150.BIOSET 3700AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008545PAQ. 110x140x140/QT-HS/ FX7202AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008552PAQ.110X140X150.GE.MAC800AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008569PAQ.110X140X140/QT-HS/OEM BEXEN XEG114AAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008583PAQ.111X100X200.ORIONAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008590PAQ.112X100X300*31*DELTA3.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008613PAQ.112X90X300.SUZ-KENZAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008637PAQ.112X100X300/QI-HS/GOLDWAYAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008644PAQ.112X90X160.CADENCEAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008651PAQ.112X100X100.SRF618BAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008668PAQ.112X100X300.ELAN1100AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008675PAQ.112X90X150.CADENCEAB MEDICA GROUP, S.A.DSF2025-07-28