FDA.reportPublic FDA data

Safespace

Primary DI
05060631840005
Brand
Safespace
Company
SAFESPACES (CORNHOLME) LIMITED
Model
100cm x 200cm x 204cm h
Catalog number
SR1901
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
FNJBed, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNJBed, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060631840005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060631840005050606318400055060631840005

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
34895262521519HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521471HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521488HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521495HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521501HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521518HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521525HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521532HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
06975575170189YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
06975575170196YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
06975575170202YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
05060631840548SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-21
05060631840012VoyagerSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840029Voyager CompactSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840500SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840517SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840760Safespace Hi-Lo CompartmentSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840524SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840531SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631843006Safespace on platform 19cmSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
50606318404940SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-10
00766923348109Stay Safe BedPEDICRAFT, INC.FNJ2025-07-21
00766923348123Stay SafePEDICRAFT, INC.FNJ2025-07-21
00845699005437SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005444SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005451SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005468SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005475SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005482SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
B773KMHBD0KLYOKLYO MEDICAL SYSTEMS INC.FNJ2024-02-23