AMC

Basic Information

• Brand Name: AMC
• Primary DI: 00849593007429
• Version / Model: CU-ST2635HP-20
• Company Name: Advantage Medical Electronics, LLC
• Labeler DUNS: 080242300
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2019-02-23
• Public Version: 3
• Public Version Date: 2023-02-10
• Public Version Status: Update
• Public Device Record Key: 2858a08e-19b0-4035-babd-20a37b3ce75c

Device Description

Disposable Cuff, Single Tube, Adult, HP Fitting

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
37326	Blood pressure cuff, single-use	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 typically wrapped around the upper arm of the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849593007429	GS1
Unit of Use	00849593070935	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063863	000