FDA.reportPublic FDA data

BIOS Living

Primary DI
00057475960018
Brand
BIOS Living
Company
Thermor Ltd
Model
SP001
Device description
Turning Cushion
Published
2024-08-19
Public version status
Update
Distribution status
Not 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
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475960015PackageGS14Not in Commercial Distribution
00057475960018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747596001510057475960015
00057475960018000574759600180574759600180057475960018

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, reusableA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a reusable device.

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
00057475238490BIOS238DI2022-03-04
00057475227494BIOS227DI2022-03-04
00057475112653BIOS112PO2022-02-25
00057475700324BIOS Living700322023-11-07
00057475800130BIOS Living800132023-11-06
00060476327049BIOS327042022-03-04
00057475244125BIOS DiagnosticsBD4122026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000465COTISENHuanghua Promisee Dental Co., Ltd.IKX2026-10-28
06954454000472COTISENHuanghua Promisee Dental Co., Ltd.IKX2026-10-28
06954454000489COTISENHuanghua Promisee Dental Co., Ltd.IKX2026-10-28
06954454001196COTISENHuanghua Promisee Dental Co., Ltd.IKX2026-10-28
06954454002131COTISENHuanghua Promisee Dental Co., Ltd.IKX2026-10-28
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00689281037402Wave Grab Bar, 18" Length, Left and Right, Brushed Stainless (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281037419Wave Grab Bar, 18" Length, Left and Right, Polished Chrome (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281038065Wave Grab Bar, 1.25x18" Length, Matte BlackHealthcraft Products Inc.IKX2026-10-13
00689281038072Wave Grab Bar, 1.25x18" Length, Brushed StainlessHealthcraft Products Inc.IKX2026-10-13
00689281038089Wave Grab Bar, 1.25x18" Length, Brushed GoldHealthcraft Products Inc.IKX2026-10-13
00689281038096Wave Grab Bar, 1.25x18" Length, Polished ChromeHealthcraft Products Inc.IKX2026-10-13
00689281038348Wave Grab Bar, 18" Length, Left and Right, Brushed Gold (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281039413Wave Grab Bar, 1.25x18" Length, Oil Rubbed BronzeHealthcraft Products Inc.IKX2026-10-13
00810226442962ViveVIVE HEALTH LLCIKX2026-10-12
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00689281038416Easy Mount™ Grab Bar, 1.25x12", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038423Easy Mount™ Grab Bar, 1.25x18", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038430Easy Mount™ Grab Bar, 1.25x24", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038447Easy Mount™ Grab Bar, 1.25x32", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281039253Easy Mount™ Grab Bar, 1.25x12", Matte Black (Textured)Healthcraft Products Inc.IKX2026-10-01
00689281039260Easy Mount™ Grab Bar, 1.25x24", Matte Black (Texture)Healthcraft Products Inc.IKX2026-10-01
00689281008006Easy Mount™ Grab Bar, 1.25x18", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008013Easy Mount™ Grab Bar, 1.25x24", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008020Easy Mount™ Grab Bar, 1.25x12", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008037Easy Mount™ Grab Bar, 1.25x18", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008044Easy Mount™ Grab Bar, 1.25x24", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008082Easy Mount™ Grab Bar, 1.25x12", KnurledHealthcraft Products Inc.IKX2026-09-30