FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094318449
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901007
Catalog number
QS-6EC-CFEAC
Device description
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
Published
2023-04-25
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
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094318449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094318449007320943184497320943184490732094318449

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary stress exercise monitoring system computerA dedicated computer with a specific software package installed intended to be used to interpret the various physiological parameters and waveforms generated during stress exercise testing of a patient while connected to a stress exercise monitoring system. These signals are provided by appropriate interfaced stress testing devices (e.g., an ergometer) using predefined pattern recognition techniques. The registered signals are compared to pre-established diagnostic criteria.

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
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

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Primary DI, Brand, Company table
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08809276943958Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
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08809276943972Cardio P1Bionet CO,LTDDPS2026-05-26
08809276944269Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276944276Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
00884838117358patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-05
00884838117273patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
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00198953107263MACGe Medical Systems Information Technologies, Inc.DPS2026-01-27
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00884838117204patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117211patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117228patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117259patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-15
00884838117266patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-15
00884838117235patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2025-12-15
00884838117242patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2025-12-15
00732094237740Welch Allyn, Inc.WELCH ALLYN, INC.DPS2025-09-22