BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Protekt Aire Replacement Pump

DI: 05060488570452 · Model: 80091 · PROACTIVE MEDICAL PRODUCTS, LLC

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Protekt Aire Replacement Pump
Primary DI: 05060488570452
Version / Model: 80091
Catalog Number: 80091
Company Name: PROACTIVE MEDICAL PRODUCTS, LLC
Labeler DUNS: 078582655
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-08-12
Public Version: 3
Public Version Date: 2025-12-19
Public Version Status: Update
Public Device Record Key: d7074f2b-5dad-442d-86d6-e5b64eb191fb
Distribution End Date: 2025-12-18

Device Description

Protekt 9000 Pump Only

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: Yes
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
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	880.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47478	Alternating-pressure bed mattress overlay system	An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060488570452	GS1

Customer Contacts

Phone: +1 855 237 7622
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	9	Inch
Length	15	Inch
Width	21	Inch