NIBP Cuffs

Basic Information

• Brand Name: NIBP Cuffs
• Primary DI: 20884838009107
• Version / Model: GENTLE CARE CUFF, ADULT XL, 1-TUBE
• Catalog Number: M4576B
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-10-28
• Public Version: 9
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: c905adc2-b3ad-4d68-80bd-2bd322d0a5d7

Device Description

Gentle Care Cuff, Adult XL, 1-tube (navy blue with edge striping). Soft Single Patient. Circumference 27.5 - 36.0 cm. 10/box.

Device Characteristics

• Single Use: No
• 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
OED	Antimicrobial 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	20884838009107	GS1
Unit of Use	00884838009103	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity