FDA.reportPublic FDA data

Trulife

Primary DI
00645517399300
Brand
Trulife
Company
TRULIFE LIMITED
Model
A37-KIT-NIH
Device description
KIT PAD/STRAP NON-INVASIVE HALO
Published
2022-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRIORTHOSIS, TRUNCAL/ORTHOSIS, LIMB

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00645517399300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00645517399300006455173993006455173993000645517399300

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck immobilizer, reusableA rigid or non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
289728891
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00645517899312TrulifeTN200-22026-04-22
00645517899329TrulifeTN200-32026-04-22
00645517899336TrulifeTN200-42026-04-22
00645517899343TrulifeTN200-52026-04-22
00645517899398TrulifeTN200-KIT2026-04-22
00645517899404TrulifeTN250-KIT2026-04-22
00645517899350TrulifeTN250-22026-02-17
00645517899367TrulifeTN250-32026-02-17
00645517899374TrulifeTN250-42026-02-17
00645517899381TrulifeTN250-52026-02-17
00645517024189Trulife08005042025-09-03
00645517323831TrulifeO109012025-09-03
00645517323848TrulifeO109022025-09-03
00645517323886TrulifeO109312025-09-03
00645517323947TrulifeO113942025-09-03
00645517510729TrulifeO109272025-09-03
00645517510743TrulifeO109282025-09-03
00645517024172Trulife08005022023-06-06
00645517325002TrulifeA378022022-12-31
00645517324104Trulife1400027R002022-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006794ILSO™PMT CORPORATIONMRI2026-07-18
00650551006800ILSO™PMT CORPORATIONMRI2026-07-17
00650551006817ILSO™PMT CORPORATIONMRI2026-07-17
00650551006824ILSO™PMT CORPORATIONMRI2026-07-17
00650551006831ILSO™PMT CORPORATIONMRI2026-07-17
00650551006848ILSO™PMT CORPORATIONMRI2026-07-17
00650551006855ILSO™PMT CORPORATIONMRI2026-07-17
00650551006862ILSO™PMT CORPORATIONMRI2026-07-17
00650551006879ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006886ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006893ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006909ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006916ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006923ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006930ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006947ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006954ILSO™PMT CORPORATIONMRI2026-07-17
00650551006961ITLSO™PMT CORPORATIONMRI2026-07-17
00850040983005WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
00850040983012WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
00850040983029WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
00645517890821TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517892757TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517892764TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517898766TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517899077TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517899121TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517897776TrulifeTRULIFE LIMITEDMRI2025-08-25
04719879646108ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646115ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10