Guardian

Primary DI
00860008160379
Brand
Guardian
Company
TURNCARE INC
Model
GS-EN-BD-76
Catalog number
GS-EN-BD-76
Device description
"Guardian System Bed Enhancer-76"", integrated tube connector"
Published
2025-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008160379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008160379008600081603798600081603790860008160379

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress overlay, reusableA pad or thin mattress, usually full-body length, which is placed on top of a bed mattress and designed with parallel chambers that are alternately filled with forced-air to actively change an 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. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106254663
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008160300GuardianGS-TBGS-TB2024-11-07
00860008160348GuardianGS-C2025-03-03
00860008160355GuardianGS-SBS-76GS-SBS-762025-03-03
00860008160362GuardianGS-SBS-76-1GS-SBS-76-12025-03-03
00860008160386GuardianGS-EN-ST-70GS-EN-ST-702025-03-03
00860008160393GuardianGS-EN-PT-70GS-EN-PT-702025-03-03
00860000205887GuardianGS-2.5-EN-PT-70GS-2.5-EN-PT-702024-11-07
00860000205894GuardianGS-2.5-EN-ST-70GS-2.5-EN-ST-702024-11-07
00860001236453GuardianGS-2.5-CGS-2.5-C2024-11-07
00860001236491GuardianGS-2.5-EN-BD-76GS-2.5-EN-BD-762024-11-07

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