FDA.reportPublic FDA data

Health o meter professional

Primary DI
00850017694279
Brand
Health o meter professional
Company
Pelstar, LLC
Model
5100
Device description
Gold Standard Rollboard, 68 x 19
Published
2022-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FMRDevice, Transfer, Patient, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017694279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017694279008500176942798500176942790850017694279

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer sliding boardA manual device used by healthcare professionals to assist in the physical movement and transfer of a person/patient (e.g., a hospitalized, a person with a disability, or a geriatric) from one position to another. The device typically has no lifting capabilities and utilizes sliding techniques to move the person. It is typically designed to transfer a person sideways from, e.g., a bed to a chair, or a bed to an operating table, or an operating table to a bed. It may be constructed as a solid sliding board with a low-friction surface, or a roller board (roller system in a framework).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037289290
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
00851628008813Health o meter professionalPTS-1000KL2022-11-22
00850017694286Health o meter professional52002022-11-16
00850017694293Health o meter professional53002022-11-16
00850017694309Health o meter professional54002022-11-16
00850017694316Health o meter professional54302022-11-16
00850017694323Health o meter professional55002022-11-16
00850017694330Health o meter professional59002022-11-16
00854896003535Health o meter professionalBABYSLINGSCALE2022-04-21
00850017694118Health o meter professional523KL2022-03-30
00850017694187Health o meter professional752KL-BT2022-03-30
00850017694194Health o meter professional752KG-BT2022-03-30
00850017694750Health o meter professional880KG2022-03-30
00851628008042Health o meter professional550KL2022-03-30
00851628008073Health o meter professional596KL2022-03-30
00851628008646Health o meter professional599KG2022-03-30
00851628008653Health o meter professional600KG2022-03-30
00851628008660Health o meter professional752KG2022-03-30
00851628008677Health o meter professional600KG-BT2022-03-30
00851628008752Health o meter professional844KL-C2022-03-30
00851628008806Health o meter professional810KL2022-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05059441537298AIRPALArjohuntleigh ABFMR2026-03-23
05059441537304AIRPALArjohuntleigh ABFMR2026-03-23
05059441537311AIRPALArjohuntleigh ABFMR2026-03-23
05059441537328AIRPALArjohuntleigh ABFMR2026-03-23
05059441537335AIRPALArjohuntleigh ABFMR2026-03-23
05059441537342AIRPALArjohuntleigh ABFMR2026-03-23
00850056748360APLS Thermal WrapINTEGRATED MEDCRAFT LLCFMR2026-02-16
07333350703745Tortoise™ Turning & positioning systemMölnlycke Health Care ABFMR2026-02-11
07333350636012Tortoise™ Turning & positioning systemMölnlycke Health Care ABFMR2026-02-11
07613327681710N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.FMR2026-02-11
06975575170103YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-02-10
06975575170028YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170035YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170042YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170059YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170097YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
00199284069657Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00199284569546Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00199284790896Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970710Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970727Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970734Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970741Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970758Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970765Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970772Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970796Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860015268808Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860015268815Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00850056748292FORWARD APLS Litter GuardINTEGRATED MEDCRAFT LLCFMR2026-01-15