FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094008227
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901043
Catalog number
3603DXUNO
Device description
CUFF TL REUSE 1 PC ADULT 2TUBE MF
Published
2016-09-17
Public version status
Update
Distribution status
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
DXQblood pressure cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094008227PackageGS15In Commercial Distribution
00732094218206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094008227007320940082277320940082270732094008227
00732094218206007320942182067320942182060732094218206

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

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
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
00732094322934Welch Allyn, Inc.901134ESCRIBE-BEX-CXAAA2019-07-22
00732094322941Welch Allyn, Inc.901134ESCRIBE-BAX-DXACX2019-07-22
00732094322958Welch Allyn, Inc.901134ESCRIBE-BAX-DXACB2019-07-22
00732094322965Welch Allyn, Inc.901134ESCRIBE-BAX-CXXXX2019-07-22
00732094322972Welch Allyn, Inc.901134ESCRIBE-BAX-CXACB2019-07-22
00732094322989Welch Allyn, Inc.901134ESCRIBE-BAX-CXACA2019-07-22
00732094322996Welch Allyn, Inc.901134ESCRIBE-BAX-CXAAX2019-07-22
00732094323009Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXX2019-07-22
00732094323016Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXA2019-07-22
00732094323023Welch Allyn, Inc.901134ESCRIBE-AEX-CXAXA2019-07-22
00732094323030Welch Allyn, Inc.901134ESCRIBE-AEX-CXAAA2019-07-22
00732094323047Welch Allyn, Inc.901134ESCRIBE-AAX-DXXXX2019-07-22
00732094323054Welch Allyn, Inc.901134ESCRIBE-AAX-CXXXX2019-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782902636Adcuff™ AMERICAN DIAGNOSTIC CORPDXQ2026-02-23
M3681097002GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682338A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682338X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452C1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823481A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823552N1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823552X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562C1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562N1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823572A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682360A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682362X2GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
00810079260089Teladoc Health, Inc.Teladoc Health, Inc.DXQ2026-02-17
00810079260003Teladoc Health, Inc.Teladoc Health, Inc.DXQ2026-02-17
16978034830133tenoviShenzhen Jamr Medical Technology Co., Ltd.DXQ2025-12-12
16978034830140tenoviShenzhen Jamr Medical Technology Co., Ltd.DXQ2025-12-12
10840935111702Straight Black Hose, Female Bayonet to Female Bayonet, 9.8ft (3m), SiemensSUNTECH MEDICAL, INC.DXQ2025-12-01
10840935111719Straight Gray Hose, Female Luer to Female Bayonet, 9.8ft (3m), SiemensSUNTECH MEDICAL, INC.DXQ2025-12-01
10840935111696Patient HoseSUNTECH MEDICAL, INC.DXQ2025-11-18
20197344165343MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
20197344165374MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
20197344165398MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165339MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165353MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165360MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14