Long Term Care Swing Rail

GUDID 00616784046723

DYNAREX CORPORATION

Bedrail
Primary Device ID00616784046723
NIH Device Record Key7e87d285-a7c4-474b-9eea-db7125f7ffac
Commercial Distribution StatusIn Commercial Distribution
Brand NameLong Term Care Swing Rail
Version Model Number10467
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count2
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784046716 [Unit of Use]
GS100616784046723 [Primary]

FDA Product Code

FNLBed, Ac-Powered Adjustable Hospital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-06-19
Device Publish Date2018-05-19

Devices Manufactured by DYNAREX CORPORATION

00810180844307 - Eye Pad Strips2026-03-18 Eye Pad Strips N/S 1cmx12cm
00840117349247 - ActiSplint with Sensi-Wrap2026-03-18 ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage, 36" ActiSplint, 2"x5 Sensi Wra
00840117348905 - Post-Op Sponges2026-03-16 Post-Op Sponges, Non-Woven, Sterile, 4" x 3", 4-Ply (10.2cm x 7.6cm)
00840117348936 - Post-Op Sponges, Non-Woven, Sterile, 4" x 4", 4-Ply (10.2cm x 10.2cm)2026-03-16
00810180844178 - CurPro Cotton Filled Gauze Sponges U.S.P.2026-03-12 2"x 2' (5.1 cm x 5.1 cm)
00616784321516 - Sensi Wrap, Self-Adherent - Latex Free 1" x 5 yds Assorted (5/color)2026-03-11
00616784321615 - Sensi Wrap, Self-Adherent, Assorted Colors- Latex Free, 2" x 5yd,2026-03-11
00616784321714 - Sensi Wrap, Self-Adherent - Latex Free 3" x 5 yds Assorted (4/color)2026-03-11

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.