Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094258486
• Version / Model: 901146
• Catalog Number: 6901-021-08
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-24
• Public Version: 2
• Public Version Date: 2022-06-28
• Public Version Status: Update
• Public Device Record Key: 0e1bde53-ff05-4fe6-a0e5-4c77ea1f3b1d

Device Description

Reusable Blood Pressure Cuff S12/S19 Thigh, 38-50 cm range

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXQ	blood pressure cuff	Cardiovascular	870.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34978	Blood pressure cuff, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094258486	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K051904	000