FDA.reportPublic FDA data

Medline

Primary DI
10888277673397
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDT828305M
Catalog number
MDT828305M
Device description
RESTRAINT,VEST,ZIP-BACK,TIE,MED
Published
2020-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
20888277673394PackageGS124In Commercial Distribution
10888277673397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827767339420888277673394
1088827767339710888277673397

GMDN Terms#

Term, Definition table
TermDefinition
Wrist binder, reusableA dedicated strip/roll of fabric or polymer material designed to be wrapped around the wrist to support the wrist joint. It does not include a rigid support (i.e., not a wrist immobilizer) and is not a tubular support bandage. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426263943Medline-MicrotekMicrotek Medical LLCFMQ2026-01-21
20884389198749MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-11-14
10190676008299PoseyPOSEY PRODUCTS, LLCFMQ2025-07-16
00749756399173DeRoyalDEROYAL INDUSTRIES, INC.FMQ2025-06-19
10810178883117ViveVIVE HEALTH LLCFMQ2025-05-19
10815614021115Elevate ArmBoard Extender HSemler Technologies, Inc.FMQ2025-05-19
10815614021122Elevate ArmBoard Extender H Semler Technologies, Inc.FMQ2025-05-19
00748426141128Medline-MicrotekMicrotek Medical LLCFMQ2025-04-08
06974737270125EMSSSHANGHAI EMSS MED&TECH CO.,LTD.FMQ2025-03-12
10815614021092mBrace 4285 Wrist Support with HookSemler Technologies, Inc.FMQ2025-02-27
00195278925428Pristina PaddleGE MEDICAL SYSTEMSFMQ2025-01-09
10888277673472MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-01-04
10197344112937MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-29
10197344112944MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-29
10197344112258MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-14
10888277699557MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-08-07
09010279001050iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
09010279001289iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
29010279001702iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
29010279001719iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10810113577484ViveVIVE HEALTH LLCFMQ2024-07-17
00749756394567DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394574DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394581DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394598DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394604DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394611DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
06931918129979HALYARDGRI Medical & Electronic Technology Co., Ltd.FMQ2024-06-11
06931918189829HALYARDGRI Medical & Electronic Technology Co., Ltd.FMQ2024-06-11
50080196281372MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01