FDA.reportPublic FDA data

Traxx Mobility Systems

Primary DI
00850056676151
Brand
Traxx Mobility Systems
Company
Traxx Mobility Systems LLC
Model
Titan 500
Device description
Medium Universal Sling
Published
2023-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSALift, patient, non-ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056676151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056676151008500566761518500566761510850056676151

GMDN Terms#

Term, Definition table
TermDefinition
Patient lifting system divided leg slingA lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their legs held apart and posterior exposed for toileting and washing. It is typically designed as a U-shaped sling construction made of strengthened fabric with lifting straps, a back support with or without head support and individual leg straps (bands) that are wrapped around each leg to support the patient/person in a sitting position with divided legs. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(734)744-8100colson@traxxms.com

Regulatory Flags#

DUNS number
025612885
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056676007Traxx Mobility SystemsTitan 5002023-10-26
00850056676014Traxx Mobility SystemsTitan 5002023-10-26
00850056676021Traxx Mobility SystemsTitan 5002023-10-26
00850056676038Traxx Mobility SystemsTitan 5002023-10-26
00850056676045Traxx Mobility SystemsTitan 5002023-10-26
00850056676052Traxx Mobility SystemsTitan 5002023-10-26
00850056676069Traxx Mobility SystemsTitan 5002023-10-26
00850056676076Traxx Mobility SystemsTitan 5002023-10-26
00850056676083Traxx Mobility SystemsTitan 5002023-10-26
00850056676090Traxx Mobility SystemsTitan 5002023-10-26
00850056676106Traxx Mobility SystemsTitan 5002023-10-26
00850056676113Traxx Mobility SystemsTitan 5002023-10-26
00850056676120Traxx Mobility SystemsTitan 5002023-10-26
00850056676137Traxx Mobility SystemsTitan 5002023-10-26
00850056676144Traxx Mobility SystemsTitan 5002023-10-26
00850056676168Traxx Mobility SystemsTitan 5002023-10-26
00850056676175Traxx Mobility SystemsTitan 5002023-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10688503001860M-SERIESSavaria Concord LiftFSA2026-03-19
10688503001853M-SERIESSavaria Concord LiftFSA2026-03-12
05059441380450Arjo Loop Ambulatory SlingArjohuntleigh ABFSA2026-03-09
05059441380467Arjo Loop Ambulatory SlingArjohuntleigh ABFSA2026-03-09
05059441380474Arjo Loop Ambulatory SlingArjohuntleigh ABFSA2026-03-09
05059441380481Arjo Loop Ambulatory SlingArjohuntleigh ABFSA2026-03-09
20197344036650MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-03-04
10688503001839M-SERIESSavaria Concord LiftFSA2026-03-04
10688503001846M-SERIESSavaria Concord LiftFSA2026-03-04
10688503001778M-SERIESSavaria Concord LiftFSA2026-02-20
10688503001785M-SERIESSavaria Concord LiftFSA2026-02-20
10688503001792M-SERIESSavaria Concord LiftFSA2026-02-20
10688503001808M-SERIESSavaria Concord LiftFSA2026-02-20
10688503001815M-SERIESSavaria Concord LiftFSA2026-02-20
00817956020224UltraLift - Tollos1073849 Ontario LimitedFSA2026-02-18
00860014768613LiftWalkINNOMOTIVE L.L.CFSA2026-02-04
00860014768668LiftWalkINNOMOTIVE L.L.CFSA2026-02-04
10688503001761M-SERIESSavaria Concord LiftFSA2026-01-28
40080196764250MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-01-27
40884389144825MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-01-27
10688503001730M-SERIESSavaria Concord LiftFSA2026-01-26
10688503001747M-SERIESSavaria Concord LiftFSA2026-01-26
10688503001754M-SERIESSavaria Concord LiftFSA2026-01-26
10688503001723M-SERIESSavaria Concord LiftFSA2026-01-15
05059441295860Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
05059441295891Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
05059441295921Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
05059441295952Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
00860014621871ValmaxSupply Line MedicalFSA2025-12-22
10688503001716M-SERIESSavaria Concord LiftFSA2025-12-12