FDA.reportPublic FDA data

INVACARE® PAINTED BED RAIL

Primary DI
00841447100027
Brand
INVACARE® PAINTED BED RAIL
Company
INVACARE CORPORATION
Model
6629P
Published
2021-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00841447100027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447100027008414471000278414471000270841447100027

GMDN Terms#

Term, Definition table
TermDefinition
BedrailA rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an "up" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(440)329-6000orders@invacare.com

Regulatory Flags#

DUNS number
076916246
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841447116547Invacare Essentials RollatorESS-ROLL02ESS-ROLL022026-07-01
00841447116745Invacare MA500X4280MMA500X4280MMA500XM42802026-07-01
00841447114635Invacare® Platinum Oxygen ConcentratorIRC9LXO2AWQL5IRC9LXO2AWQL52026-07-21
00841447114642Invacare® Perfecto2V Oxygen ConcentratorIRC5PO2VAWL5IRC5PO2VAWL52026-07-21
05600494139948Invacare Birdie Evo XPlus Full Body LiftBRDXPLUSBRDXPLUS2026-06-03
00841447116431Invacare® Alternating Air Mattress & PumpMA101BLMA101BL2026-05-01
00841447116448Invacare® Alternating Air Mattress & PumpMA101BKMA101BK2026-05-01
00841447116455Invacare® Alternating Air Mattress & Pump with Static ModeMA102BLMA102BL2026-05-01
00841447116462Invacare® Alternating Air Mattress & Pump with Static ModeMA102BKMA102BK2026-05-01
00841447116479Easy Glide Transport Chair for InvacareEGTC19STFSBUEGTC19STFSBU2026-04-10
00841447116486Easy Glide Transport Chair for InvacareEGTC19STFSBKEGTC19STFSBK2026-04-10
00841447116493Easy Glide Transport Chair for InvacareEGTC19STRSBUEGTC19STRSBU2026-04-10
00841447116509Easy Glide Transport Chair for InvacareEGTC19STRSBKEGTC19STRSBK2026-04-10
00841447116516Easy Glide Transport Chair for InvacareEGTC19ALRSBUEGTC19ALRSBU2026-04-10
00841447116523Easy Glide Transport Chair for InvacareEGTC19ALRSBKEGTC19ALRSBK2026-04-10
00841447109754Invacare® Think Soft® Long Term Care Bed Positioning DeviceIHCSTSPD-QSPIHCSTSPD-QSP2026-03-02
00841447116301Easy Glide Wheelchair for InvacareEGWC16STRSBUEGWC16STRSBU2026-02-13
00841447116318Easy Glide Wheelchair for InvacareEGWC16STRSBKEGWC16STRSBK2026-02-13
00841447116325Easy Glide Wheelchair for InvacareEGWC16STREBUEGWC16STREBU2026-02-13
00841447116332Easy Glide Wheelchair for InvacareEGWC16STREBKEGWC16STREBK2026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344119059MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-08-27
10197344119066MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-08-27
10884389161692MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-08-27
10888277363021MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-08-27
20193489003687MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-08-27
20193489004035MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-08-27
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
05060631843129Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843136Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12