FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
10817655021161
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901136
Catalog number
9100-026-04
Device description
Assurance Paper, cued with header 8.5 in x 11 in. For use with EL 250 and 250c, ELI 280, and ELI 350. 250 sheets/pack, 12 packs/case. Price per pack
Published
2020-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
10817655021161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081765502116110817655021161

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic recording paperA device prepared from a thin sheet of fibrous material, typically with preprinted graphics and designed for recording the output of an electrocardiograph (ECG), or other device, in the form of measured physiologic parameters as an electrocardiogram (ECG). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
198227881
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
00732094055245Welch Allyn, Inc.901001SM25512026-03-06
00887761976283Life2000MS-01-01252026-02-09
00887761978041Life2000MS-01-01212026-02-09
00732094360363Welch Allyn, Inc.901144QS-6AA-AEAAA2026-02-03
00732094360370Welch Allyn, Inc.901144XSCRIBE-6AA-ACAAA2026-02-03
00732094360295Welch Allyn, Inc.901204 v7.4.2E100012025-12-18
00732094357929Welch Allyn, Inc.90102671-XM2LXE2025-11-25
00732094358933Welch Allyn, Inc.901203C360KIT95RXTBWLJBP2025-11-24
00732094358957Welch Allyn, Inc.901203C360KIT95MXTBWLJBP2025-11-24
00732094358971Welch Allyn, Inc.901203C360KIT95CXTBWLJBP2025-11-24
00732094358988Welch Allyn, Inc.901203C360KIT95CXTBMBJX2025-11-24
00732094237740Welch Allyn, Inc.901049CP150A2025-09-22
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094356380Welch Allyn, Inc.9010069293-046-062025-09-22
00732094356397Welch Allyn, Inc.9010069293-046-052025-09-22
00732094356403Welch Allyn, Inc.9010069293-046-042025-09-22
00732094356410Welch Allyn, Inc.9010069293-046-032025-09-22
00732094309225Welch Allyn, Inc.90105744XT2021-04-26
06932825304237Welch Allyn, Inc.9011232000 PLUS-A2025-08-08

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