FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094258738
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901006
Catalog number
015-0630-00
Device description
Blue Max Supatab resting tab electrodes, wet gel, 33mm (1.30 in.). 100 electrodes/pack. Price per pack. Must order in increments of 24.
Published
2020-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLDMONITOR, ST SEGMENT WITH ALARM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLDMonitor, St Segment With AlarmCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972121000ACUITY CENTRAL STATIONProtocol Systems, Inc.1997-11-07MLD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094258738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094258738007320942587387320942587380732094258738

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. 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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094319903Welch Allyn, Inc.9010114198322023-09-26
00732094326079Welch Allyn, Inc.9010069293-024-512023-08-25
00732094247138Welch Allyn, Inc.90103139500-TE2019-08-28
00732094247145Welch Allyn, Inc.90103139500-NP-TE2019-08-28
00732094272338Welch Allyn, Inc.90115211094-001-502020-03-24
00732094258905Welch Allyn, Inc.90113411012-014-502020-03-20
00732094307351Welch Allyn, Inc.9011454197512019-10-23
00732094307368Welch Allyn, Inc.9011454133792019-10-23
00732094307375Welch Allyn, Inc.9011454197332019-10-23
00732094258998Welch Allyn, Inc.901011036840-0052019-09-26
00732094272673Welch Allyn, Inc.901011036840-0062019-09-26
00817655020679Welch Allyn, Inc.90113411012-016-502019-09-26
00817655020686Welch Allyn, Inc.90113411012-016-512019-09-26
00732094296341Welch Allyn, Inc.90101211093-003-502019-06-11
00732094223910Welch Allyn, Inc.9011084112152023-08-24
00732094089226Welch Allyn, Inc.901020118402016-09-17
00732094089240Welch Allyn, Inc.901022118202016-09-17
00732094183948Welch Allyn, Inc.90102211820-L2016-09-17

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Primary DI, Brand, Company table
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00840682147811CARESCAPE SoftwareGE Healthcare Finland OyMLD2026-04-15
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06944413838413Patient MonitorEdan Instruments, Inc.MLD2025-09-05
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B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MLD2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MLD2024-12-19
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