FDA.reportPublic FDA data

Medline

Primary DI
10080196281374
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDT822126
Catalog number
MDT822126
Device description
BELT,SECURITY,SAFETY-SOFT,POLY,2PC
Published
2024-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMQRestraint, protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50080196281372PackageGS124In Commercial Distribution
10080196281374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5008019628137250080196281372
1008019628137410080196281374

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196310128MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-06-03
10748426141125Medline-MicrotekMicrotek Medical LLCFMQ2025-04-08
09010279001708iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
09010279001715iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
M1435040070Protective Vest No SleeveKenad SG Medical, Inc.FMQ2023-09-17
10810087352766CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353022CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353039CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353046CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353053CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353060CoulmedCoulmed Products Group LLCFMQ2023-01-06
10190676003232POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676003348POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676003355POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005441POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005458POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005465POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676001016POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676001085POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676001108POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002518POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002525POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002532POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002549POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002556POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002563POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002570POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002594POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002600POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002617POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05