FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094323931
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901139
Catalog number
S2-P-AXX-XXX
Device description
S2 telemetry transmitter supporting a 4 and 5 wire patient cable for diagnostic quality ECG acquisition and transmission via standard IEEE 802.11a b g n WLAN at 2.4 and 5 GHz , capacitive touch control and menu navigation with 2.8 inch antiglare color display , heart rate display when actively communicating with monitoring node , water resistant protection with IPX4 rating , includes rechargeable Lithium ion battery pack with 32 hour typical runtime, single use clip on pouch and user instructions.
Published
2023-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094323931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094323931007320943239317320943239310732094323931

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electrocardiographicA small unit dedicated to the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG parameter/information measured and provided by this module.

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
00732094272222Welch Allyn, Inc.90114533193-001-512019-09-26
00732094262551Welch Allyn, Inc.901011SCNODE-DEB-CXXXX2019-09-25
00732094288773Welch Allyn, Inc.9011441081912020-11-10
00732094288780Welch Allyn, Inc.9011441081902020-11-10
00732094272086Welch Allyn, Inc.90109541000-032-572020-02-19
00732094272154Welch Allyn, Inc.90114533193-106-532019-09-26
00732094272161Welch Allyn, Inc.90114533193-106-522019-09-26
00732094272178Welch Allyn, Inc.90114533193-106-512019-09-26
00732094271782Welch Allyn, Inc.901007ACC-ELI280-A2019-07-24
00732094265125Welch Allyn, Inc.901134ESWK-AEB-BXXXX2019-09-17
00732094271812Welch Allyn, Inc.901095ACC-BUR280-B2019-09-13
00732094272116Welch Allyn, Inc.90109541000-031-572019-09-13
00732094271768Welch Allyn, Inc.901007ACC-ELI380-A2019-09-12
00732094322866Welch Allyn, Inc.901134ESCRIBE-CAX-DXACB2019-07-22
00732094322873Welch Allyn, Inc.901134ESCRIBE-CAX-CXXXX2019-07-22
00732094322880Welch Allyn, Inc.901134ESCRIBE-CAX-CXACX2019-07-22
00732094322897Welch Allyn, Inc.901134ESCRIBE-CAX-CXACA2019-07-22
00732094322903Welch Allyn, Inc.901134ESCRIBE-BEX-CXXXA2019-07-22
00732094322910Welch Allyn, Inc.901134ESCRIBE-BEX-CXXCA2019-07-22
00732094322927Welch Allyn, Inc.901134ESCRIBE-BEX-CXACA2019-07-22

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Primary DI, Brand, Company table
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