FDA.reportPublic FDA data

Chart, X-Ref Puritan Bennett 004057

Primary DI
00817081025804
Brand
Chart, X-Ref Puritan Bennett 004057
Company
A-M SYSTEMS, LLC
Model
Chart, X-Ref Puritan Bennett 004057 - 141100
Catalog number
141100
Device description
Chart, X-Ref Puritan Bennett 004057, 8.5 x 11, with Questionnaire
Published
2020-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00817081025811PackageGS1100In Commercial Distribution
00817081025804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081025811008170810258118170810258110817081025811
00817081025804008170810258048170810258040817081025804

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.

Contacts#

Phone, Email table
PhoneEmail
3606838300sales@a-msystems.com

Regulatory Flags#

DUNS number
020275145
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817081028621Pulmonary Function Test Kit B, 36 MM O.D.PFT KIT B - 1841141841142026-04-24
00817081028607PFT Kit B, Disposable, 34 MMPFT Kit B, Disposable, 34 MM - 1831021831022025-11-06
00817081028584VBMax30E, Disposable PF Testing FilterVBMax30E - 1463091463092025-10-20
00817081028546VBMax28s, PF Testing Filter Labeled DR BurtonVBMax28s, DR Burton - VBMax28s1369042025-08-07
00817081028560VBMax28e, PF Testing Filter Labeled DR BurtonVBMax28e, DR Burton - VBMax28e1469042025-08-07
00817081028553VBMax28s, PF Testing Filter Labeled DR BurtonVBMax28s, DR Burton - VBMax28s1369042025-08-07
00817081028577VBMax28e, PF Testing Filter Labeled DR BurtonVBMax28e, DR Burton - VBMax28e1469042025-08-07
00817081028508VBMAX34, DISPOSABLE PF TESTING FILTERVBMAX34 - 1564002025-06-25
00817081028522PFT KIT J, VBMax34S w/ Blue Rubber Nose clipPFT KIT J, VBMax34S - 1871741871742025-06-25
00817081028515VBMAX34, DISPOSABLE PF TESTING FILTERVBMAX34 - 1564002025-06-25
00817081028539PFT KIT J, VBMax34S w/ Blue Rubber Nose clipPFT KIT J, VBMax34S - 1871741871742025-06-25
00817081028485VBMax34, PF Testing Filter Labeled DR BurtonVBMax34, PF Testing Filter - 1564041564042025-06-03
00817081028492VBMax34, PF Testing Filter Labeled DR BurtonVBMax34, PF Testing Filter - 1564041564042025-06-03
00817081028461PFT Kit B, VBMax35PFT Kit B, VBMax35 - 1801141801142025-05-12
00817081028478PFT Kit B, VBMax35PFT Kit B, VBMax35 - 1801141801142025-05-12
00817081028447PFT Kit J, VBMax31SPFT Kit J, VBMax31S - 1871411871412025-05-02
00817081028454PFT Kit J, VBMax31SPFT Kit J, VBMax31S - 1871411871412025-05-02
00817081028409VBMax28, PF Testing FilterVBMax28, PF Testing Filter - 1569041569042025-04-03
00817081028423PFT Kit B, VBMax35 w/ Blue Foam Nose clipPFT Kit B, VBMax35 - 1801151801152025-04-03
00817081028416VBMax28, PF Testing FilterVBMax28, PF Testing Filter - 1569041569042025-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838120358Thermal Printer Kit, USBPhilips Medizin Systeme Böblingen GmbHDSF2026-06-04
08428763001751ROLLO 57X15X12E/GR60/MICROTR.AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001768ROLLO 57X15X12E/GR60/SPIRO501AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001775ROLLO 57X25X12E.AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001782ROLLO 57X15X12E.MATACHANAAB MEDICA GROUP, S.A.DSF2025-11-12
08428763001805ROLLO 57X40X12E.PRINTER.AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001812ROLLO 58X8X12E/GR60.PRINTERAB MEDICA GROUP, S.A.DSF2025-11-12
08428763007593PAQ.112X100X100BIOCAREAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008712PAQ.112X150X300.HEARTSCREEN CLINICAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008729PAQ.112X100X160.BIOCAREAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008736PAQ.112X90X160.CADENCE M50-78019AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008743PAQ.112X90X300.CARDICO-601AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008750PAQ.112X100X100BIOCAREAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008767PAQ.114X100X150.FETATRACK310AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008774PAQ.114X70X250/QT-75HS/WELCH ALLYN CP-5AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008798PAQ.120X100X150*31*CTG.FHR240AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008811PAQ.120X100X150*31*CTG.FHR200AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008859PAQ.120X100X300.K360/AR1200AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008866PAQ.120X150X250.ERGOCID.ATAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008873PAQ.120X100X300.AR1200AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008880PAQ.120x150x300 SPACELABS 90469AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008897PAQ. 120x100x(2x150) AR1200-OEM ET MEDIAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008927PAQ.126X150X170*31*OTE-120.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008941PAQ.126X150X150*31*OTE-120.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008989PAQ.134X100X300*31*DELTA-3.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763009009PAQ.135X140X150*31*SCH.AT5AB MEDICA GROUP, S.A.DSF2025-11-12
08428763009030PAQ.143X150X300*31*SONICAIDAB MEDICA GROUP, S.A.DSF2025-11-12
08428763009047PAQ.143X150X300*31*SONICAID-NAB MEDICA GROUP, S.A.DSF2025-11-12
08428763009061PAQ.144X75X400*31*BOSCH-FK.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763009078PAQ.144X150X400*31*CRDT-3.MN.AB MEDICA GROUP, S.A.DSF2025-11-12