FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094003529
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901056
Catalog number
45ME0-E1G
Device description
Welch Allyn Spot LXi Vital Signs Device with Masimo SpO2, Braun ThermoScan PRO 4000 Thermometry, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, BMI Calculation, 50-Reading Memory, Connectivity Ready; 100-240 V, 50-60 Hz AC, Lead-Acid (#4500-84) Battery; IEC Plug Type-B
Published
2017-12-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00732094003529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094003529007320940035297320940035290732094003529

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check analysis system, clinicalAn electrically-powered device assembly, possibly with a rechargeable battery, designed to electronically measure and display multiple patient physiological parameters [e.g., noninvasive blood pressure (NIBP), pulse rate, temperature, and haemoglobin oxygen saturation (SpO2)] for intermittent spot-check measuring by a healthcare professional; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe). It may be attached to a wheeled stand or wall-mounted.

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
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094084610Welch Allyn, Inc.901092DS45-112016-09-17
00732094089479Welch Allyn, Inc.901081117202016-09-17
00817655023106Welch Allyn, Inc.9011454197342019-10-23
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

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Primary DI, Brand, Company table
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