FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094105254
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901057
Catalog number
53NT0-E4
Device description
Welch Allyn Series 300 Vital Signs Monitor with Nellcor SpO2, SureTemp Plus Thermometry, Non-invasive Blood Pressure, Pulse Rate, MAP; Supports Adult, Pediatric, and Neonatal Patients; 230 V, 50 Hz AC, IEC Plug Type-E/F
Published
2020-01-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101680000WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIESWelch Allyn, Inc.2010-07-09DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094105254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094105254007320941052547320941052540732094105254

GMDN Terms#

Term, Definition table
TermDefinition
Transportable physiologic monitoring systemAn assembly of battery-powered devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of a patient in transit [e.g., during transport to, between, or within a hospital(s)]. It typically includes a recorder, amplifier, display monitor, and patient leads/attachments; it may also be used by the bedside where it is normally connected to the mains electricity.

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094354959Welch Allyn, Inc.901130ELI230-ADA-AAAAX2026-06-09
00732094335392Welch Allyn, Inc.90105875RT2022-10-03
00732094335422Welch Allyn, Inc.90105874RT2021-08-25
00732094335439Welch Allyn, Inc.90105874RE2021-08-25
00732094335446Welch Allyn, Inc.90105873RT2021-09-28
00732094335453Welch Allyn, Inc.90105873RE2020-05-15
00732094338751Welch Allyn, Inc.90105874WX2020-08-26
00732094338768Welch Allyn, Inc.90105874WT2020-08-26
00732094338775Welch Allyn, Inc.90105874WE2020-08-26
00732094335385Welch Allyn, Inc.90105875RX2023-04-26
00732094335408Welch Allyn, Inc.90105875RE2023-04-26
00732094335415Welch Allyn, Inc.90105874RX2023-04-26
00732094209167Welch Allyn, Inc.90105875WT-B2017-12-05
00732094209334Welch Allyn, Inc.90105875MX-B2017-12-05
00732094209372Welch Allyn, Inc.90105875MT-B2017-12-05
00732094209518Welch Allyn, Inc.90105875CT-B2017-12-05
00732094209570Welch Allyn, Inc.90105875CE-B2017-12-05
00732094209679Welch Allyn, Inc.90105874MT-B2017-12-05
00732094209792Welch Allyn, Inc.90105874CX-B2017-12-05
00732094209860Welch Allyn, Inc.90105874CT-B2017-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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