SofCare

Basic Information

• Brand Name: SofCare
• Primary DI: 07613327278576
• Version / Model: 2780-800-000
• Catalog Number: 2780-800-000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 078470558
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2022-09-14
• Public Version Status: Update
• Public Device Record Key: d9ea2f14-5c56-44d4-b902-b264c92d5b08
• Distribution End Date: 2021-02-23

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: Yes
• 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
IOQ	BED, FLOTATION THERAPY, POWERED	Physical Medicine	890.5170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47476	Air-filled bed mattress overlay	A static-air-inflated pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	57613327278571	GS1	case	6	Not in Commercial Distribution	2021-02-23
Primary	07613327278576	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -40 – 140 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity