FDA.reportPublic FDA data

Direct Supply

Primary DI
00817492013148
Brand
Direct Supply
Company
Hoffmann NOA Medical Industries, LLC
Model
7040049
Device description
TRAPEZE - Floor (Beige)
Published
2023-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817492013148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817492013148008174920131488174920131480817492013148

GMDN Terms#

Term, Definition table
TermDefinition
Bed traction frameAn adjustable support structure usually attached to a patient's bed and designed for management of various orthopaedic conditions. It typically consists of a steel tubing structure that includes brackets and/or pulleys; it includes a post for the headboard and/or footboard, and often an adjustable-length top bar or rail with a hanging trapeze. The device is designed for use in combination with weights and/or other attachments to produce the desired traction in patients while permitting some freedom of motion. It is used to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118483654
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817492013254Paneca Flex Care Bed1090003-02026-01-23
00817492013261Panacea Flex Care Bed w/Safety Lock1090003-12026-01-23
00817492013278Paneca Flex Care Plus Bed1090004-02026-01-23
00817492013285Panacea Flex Care Plus Bed w/Safety Lock1090004-12026-01-23
00817492013292Panacea Essential Bed1090001-02026-01-23
00817492013308Panacea Essential Bed w/ Safety Lock1090001-12026-01-23
00817492013230Panacea Essenital Plus Bed1090002-02026-01-02
00817492013247Panacea Essential Plus w/Safety Lock1090002-12026-01-02
00000081749201Direct Supply1090001-02025-10-21
00008174920100Direct Supply1090001-12025-10-21
00087492013251Panacea Essential+1090003-02026-01-02
00087492013268Panacea Essential + with Safety Lock1090003-12026-01-02
00087492013275Panacea Flex Care +1090004-02026-01-02
00087492013282Panacea Flex Care + w/Safety Lock1090004-12026-01-02
00817492013223NOA Medical Industries10550722025-06-19
00817492013131Direct Supply7520016BEI2023-11-29
00817492013155Direct Supply70400522023-11-29
00817492013162NOA Medical Industries, LLC70400532023-11-29
00817492013179Direct Supply7520018BEI2023-11-29
00817492013209NOA Medical Industries, LLC11500002024-12-04

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Primary DI, Brand, Company table
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04719876191625TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
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