Spencer

Basic Information

• Brand Name: Spencer
• Primary DI: 08057711231669
• Version / Model: QM22300A CDK ORANGE - TAPERED VACUUM MATTRESS
• Company Name: SPENCER ITALIA SRL
• Labeler DUNS: 442102067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-26
• Public Version: 1
• Public Version Date: 2023-11-03
• Public Version Status: New
• Public Device Record Key: 9e718d5f-3d9c-446f-b740-110bf5c798a4

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35185	Patient positioning vacuum mattress	A device designed to position and immobilize a patient's full-body typically during therapeutic interventions or patient transportation. The device immobilizes the body by encompassing it and then applying a vacuum. The device is typically an airtight soft pillow case type of covering made of flexible materials, e.g., plastic or rubber. When sealed, this device retains the shape of the body that it encompasses until the vacuum is released.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08057711231669	GS1