Home GUDID 00616784562834 Deluxe Head Immobilizer
Primary DI 00616784562834
Brand Deluxe Head Immobilizer
Company DYNAREX CORPORATION
Model 5628
Device description Deluxe Head Immobilizer, Orange
Published 2021-09-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MRI Orthosis, Truncal/Orthosis, Limb
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00616784562834 Package GS1 5 In Commercial Distribution 00616784562827 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00616784562834 00616784562834 616784562834 0616784562834 00616784562827 00616784562827 616784562827 0616784562827
GMDN Terms# Term, Definition table Term Definition Head/neck immobilizer, single-use A rigid or non-rigid, non-sterile, device usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a single-use device.
Regulatory Flags# DUNS number 008124539 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 true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840117320987 Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc Canister 32409 2026-09-25 00840117352735 dmecare Solutions Folding Beside Commode 10370 2021-04-22 00840117352742 dmecare Solutions Elongated Folding Bedside Commode 10371 2021-04-22 00840117308855 Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL 34221 2022-05-11 00616784431321 Junior Tongue Depressors, 5 1/2" (14.0 cm) 4313 2021-09-01 00616784431420 Senior Tongue Depressors, 6" (15.2 cm) 4314 2021-09-01 00616784435213 Gait Belt, Natural Colors, Metal Buckle, 60" x 2" 4352 2021-09-01 00616784435312 Gait Belt, Multicolor, Metal Buckle, 60" x 2" 4353 2021-09-01 00616784435411 Gait Belt, Multicolor, Wipeable Plastic Buckle, 60" x 2" 4354 2021-09-01 00616784351612 Heavy Duty Fitted Cot Sheet, White, 30" x 73" 3516 2021-09-01 00616784351711 Premium Flat Cot Sheet, Dark Blue, 40" x 85" 3517 2021-09-01 00616784368115 Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56" 3681 2021-09-01 00616784369228 Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd 3692 2021-09-01 00616784369327 Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd 3693 2021-09-01 00616784369426 Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd 3694 2021-09-01 00616784369624 Cotton Stockinette 3696 2021-09-01 00840117349841 IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm) 7055 2026-06-30 00616784201221 Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue 2012 2021-09-01 00616784201320 Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue 2013 2021-09-01 00616784201429 Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue 2014 2021-09-01
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