FDA.reportPublic FDA data

MEDLINE

Primary DI
10080196310128
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MDT823243
Catalog number
MDT823243
Device description
PROTECTOR,MITT,HAND,CONTROL,SAFETY CHECK
Published
2025-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10080196310128PrimaryGS10
80080196310127Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019631012810080196310128
8008019631012780080196310127

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, reusableA non-rigid device, typically a strap(s) or 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 reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
2
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277198739MEDLINEMEDLINE INDUSTRIES, INC.FMQ2026-09-18
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00810101280702feather swaddle™LITTLE SPARROWS TECHNOLOGIES LLCFMQ2026-07-27
00810101280719sparrow swaddle™ - preemie infant sizeLITTLE SPARROWS TECHNOLOGIES LLCFMQ2026-07-27
00195278925428Pristina PaddleGE MEDICAL SYSTEMSFMQ2025-01-09
09010279001708iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
09010279001715iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10080196281374MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01
M1435040070Protective Vest No SleeveKenad SG Medical, Inc.FMQ2023-09-17
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
10190676002624POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002631POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05