FDA.reportPublic FDA data

BIOS Living

Primary DI
20057475282749
Brand
BIOS Living
Company
Thermor Ltd
Model
LH274
Device description
INSTANT COLD PACK (L)
Published
2024-03-21
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
true

Product Codes#

Code, Name table
CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00057475827441PackageGS112In Commercial Distribution
10057475282742PackageGS14In Commercial Distribution
20057475282749PackageGS112In Commercial Distribution
00057475282745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00057475827441000574758274410574758274410057475827441
1005747528274210057475282742
2005747528274920057475282749
00057475282745000574752827450574752827450057475282745

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, single-useA non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel, peat) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246883458
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
00057475000561BIOS Living59056L2023-03-31
00057475000578BIOS Living59057L2023-03-31
00057475000585BIOS Living59058L2023-03-31
00057475032500BIOS DiagnosticsW2502026-01-19
00057475160517BIOS DiagnosticsNS1602024-06-17
00057475210175BIOS LivingLK0172023-09-15
00057475210182BIOS LivingLK0182023-09-15
00057475210229BIOS LivingLK0222023-09-18
00057475210427BIOS LivingLK0422023-03-31
00057475210434BIOS LivingLK0432023-03-31
00057475210441BIOS LivingLK0442023-03-31
00057475210458BIOS LivingLK0452023-03-31
00057475210465BIOS LivingLK0462023-03-31
00057475210472BIOS LivingLK0472023-03-31
00057475210489BIOS LivingLK0482023-03-31
00057475211301BIOS LivingLK1302023-09-18
00057475220495BIOS Diagnostics220DI2023-09-20
00057475239497BIOS239DI2023-05-23
00057475242015BIOSBD2012022-03-04
00057475242404BIOSBD2402022-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196158652MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.IMD2026-07-16
00808829131321Lucky Super SoftDELTA BRANDS INC.IMD2026-07-10
00049696561518B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696562102B.PUREFOURSTAR GROUP INC.IMD2026-06-09
08436587170522ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-18
08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170027ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170065ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170102ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170225ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170232ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170249ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170362ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170386ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170553ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170560ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170577ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170638ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170812ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170843ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170867ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170942ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170966ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170973ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171017ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171031ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171208ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171253ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171284ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171314ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15