FDA.reportPublic FDA data

Cosyfit Hi-Lo Profiling Standard

Primary DI
05060631843129
Brand
Cosyfit Hi-Lo Profiling Standard
Company
SAFESPACES (CORNHOLME) LIMITED
Model
183cm x 91cm - 91cm sides
Catalog number
SR191117
Published
2025-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLIBed, Therapeutic, Ac-Powered, Adjustable Home-UseGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060631843129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060631843129050606318431295060631843129

GMDN Terms#

Term, Definition table
TermDefinition
Safe environment patient enclosureA freestanding, framed, tent-like structure designed to be constructed on site to function as a temporary enclosure for safe playing, resting or sleeping, typically for a patient with autism, epilepsy, challenging behaviours and/or learning difficulties. It has a soft fabric/plastic interior with padded regions to prevent injury, and a limiting and low-stimulation environment. It can be used in the home or during travel for a patient of any age. This is a reusable device.

Regulatory Flags#

DUNS number
349371893
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060631840548Safespace300cm x 300cm x 204cm hSR19062025-11-21
05060631842580Cosyfit standard/Extra Wide183cm x 183cm - 107cm sides SR202742025-11-21
05060631840104Cosyfit standard183cm x 91cm - 107cm sides SR19692025-11-12
05060631840111Cosyfit standard183cm x 91cm - 122cm sides SR19702025-11-12
05060631840128Cosyfit standard183cm x 91cm - 147cm sides SR19712025-11-12
05060631840210Cosyfit standard/Wide 183cm x 122cm - 91cm sides SR202592025-11-12
05060631840227Cosyfit standard/Wide 183cm x 122cm - 107cm sides SR20422025-11-12
05060631840234Cosyfit standard/Wide 183cm x 122cm - 122cm sides SR19722025-11-12
05060631840272Cosyfit Long/Wide198cm x 122cm - 91cm sides SR202592025-11-12
05060631840289Cosyfit Long/Wide198cm x 122cm - 107cm sides SR202752025-11-12
05060631840302Cosyfit Long/Wide198cm x 122cm - 147cm sides SR19852025-11-12
05060631840388Cosyfit standard/Extra Wide183cm x 183cm - 91cm sidesSR20492025-11-12
05060631840418Cosyfit standard/Extra Wide183cm x 183cm - 122cm sides SR19732025-11-12
05060631840425Cosyfit standard/Extra Wide183cm x 183cm - 147cm sidesSR19752025-11-12
05060631840456Cosyfit Long/Extra Wide198cm x 198cm - 91cm sides SR20532025-11-12
05060631840463Cosyfit Long/Extra Wide198cm x 198cm - 107cm sides SR20542025-11-12
05060631840470Cosyfit Long/Extra Wide198cm x 198cm - 122cm sides SR19842025-11-12
05060631840487Cosyfit Long/Extra Wide198cm x 198cm - 147cm sides SR19862025-11-12
05060631840524Safespace200cm x 300cm x 204cm hSR20132025-11-12
05060631840531Safespace250cm x 300cm x 204cm h SR19052025-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344215454MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344215461MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344215478MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344176618MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-03-16
10197344176601MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-03-13
00815027012628DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00815027012635DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00815027012895DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00841447116295Invacare® Bed Extender HeadspringINVACARE CORPORATIONLLI2025-12-05
05060631842580Cosyfit standard/Extra WideSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-21
05060631840036Siesta SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840166Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840173Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840180Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840364Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841101Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841194Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841200Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631842610Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843082Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843099Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843105Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843136Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843143Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840104Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840111Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840128Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840210Cosyfit standard/Wide SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840227Cosyfit standard/Wide SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840234Cosyfit standard/Wide SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12