FDA.reportPublic FDA data

APEX

Primary DI
00810055880003
Brand
APEX
Company
JOERNS HEALTHCARE, LLC
Model
HML400
Device description
"LIFTER,MANUAL,w/4""CASTERS HME"
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810055880003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055880003008100558800038100558800030810055880003

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient lifting system sling/harnessA general-purpose 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 body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790937150
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055885695DOLPHIN FIS 48X82X10 AUTOVECTOR SYSTEM UKDLPH-4882OOUKJ-KIT2026-08-26
00810055885701SYSTEM, DLPH PEDIATRIC CRIB, UKDLPP-2850CBUKJ-KIT2026-08-26
00810055885718DOLPHIN FIS 35X82X10 AUTOVECTOR SYSTEM UKDLPH-3582OOUKJ-KIT2026-08-26
00810055885725SYSTEM, 33X82X10, DOLPHIN PEDIATRIC, UKDLPP-3382OOUKJ-KIT2026-08-26
00810055885732DOLPHIN 33.5 X 82 AUTOVECTOR SYSTEMDLPH-3382OOUKJ-KIT2026-08-26
00810055885428SLING,QFIT PAD,SOLID,SMALLSL1000P-BV2026-08-25
00810055885435SLING,QFIT PAD,SOLID,MEDIUMSL1003P-BV2026-08-25
00810055885442SLING,QFIT,NET,MEDIUMSL1004-BV2026-08-25
00810055885459SLING,QFIT PAD,SOLID,LARGESL1006P-BV2026-08-25
00810055885466SLING,QFIT DLUX,SOLID,SMALLSL1050-BV2026-08-25
00810055885473SLING,QFIT DLUX,SOLID,MEDIUMSL1053-BV2026-08-25
00810055885480SLING,QFIT DLUX,NET,MEDIUMSL1054-BV2026-08-25
00810055885497SLING,QFIT DLUX,SOLID,LARGESL1056-BV2026-08-25
00810055885503SLING,QFIT DLUX,NET,LARGESL1057-BV2026-08-25
00810055885510SLING,L/S PLAIN,SOLID,SMALLSL1100-BV2026-08-25
00810055885527SLING,L/S PLAIN,NET,MEDIUMSL1104-BV2026-08-25
00810055885534SLING,STANDING DLUX,SOLID,LARGESL13498N-BV2026-08-25
00810055885541SLING,STANDING DLUX,SOLID,SMALLSL13499N-BV2026-08-25
00810055885558SLING,STANDING DLUX,SOLID,MEDIUMSL13500N-BV2026-08-25
00810055885565SLING,TRANSPORT DLUX,SOLID,MEDIUMSL13501N-BV2026-08-25

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