FDA.reportPublic FDA data

MEDI

Primary DI
00636257006580
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
CA11354
Device description
COMFORT ARM 15-20 LONG EW BLACK IV
Published
2019-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILGSTOCKING, ELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILGStocking, ElasticPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636257006580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257006580006362570065806362570065800636257006580

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for a hospitalized patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags#

DUNS number
960754430
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636257213469MEDIDB1812026-05-07
00636257213551MEDISP171N12026-05-07
00636257213568MEDISP171N22026-05-07
00636257213575MEDISP171N32026-05-07
00636257213582MEDISP171N42026-05-07
00636257213599MEDISP171N52026-05-07
00636257213605MEDISP172N12026-05-07
00636257213612MEDISP172N22026-05-07
00636257213629MEDISP172N32026-05-07
00636257213636MEDISP172N42026-05-07
00636257213643MEDISP172N52026-05-07
00636257213650MEDISM171N12026-05-07
00636257213667MEDISM171N22026-05-07
00636257213674MEDISM171N32026-05-07
00636257213681MEDISM171N42026-05-07
00636257213698MEDISM171N52026-05-07
00636257213704MEDISM172N12026-05-07
00636257213711MEDISM172N22026-05-07
00636257213728MEDISM172N32026-05-07
00636257213735MEDISM172N42026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874682402Tournisec62K SOLUTIONS, LLCILG2025-12-15
00199874723976Tournisec62K SOLUTIONS, LLCILG2025-12-15
10199874723973Tournisec62K SOLUTIONS, LLCILG2025-12-15
10199874682409Tournisec62K SOLUTIONS, LLCILG2025-12-15
00818323021783ViveVIVE HEALTH LLCILG2024-09-06
00818323021790ViveVIVE HEALTH LLCILG2024-09-06
10818323021780ViveVIVE HEALTH LLCILG2024-09-06
10818323021797ViveVIVE HEALTH LLCILG2024-09-06
10850053289382SURGYCOSurgyco LLCILG2023-12-15
10850053289399SURGYCOSurgyco LLCILG2023-12-15
10850053289405SURGYCOSurgyco LLCILG2023-12-15
10850053289412SURGYCOSurgyco LLCILG2023-12-15
00850053289385SURGYCOSurgyco LLCILG2023-12-15
00850053289392SURGYCOSurgyco LLCILG2023-12-15
00850053289408SURGYCOSurgyco LLCILG2023-12-15
00850053289415SURGYCOSurgyco LLCILG2023-12-15
00810113570488ViveVIVE HEALTH LLCILG2023-08-23
10810113570485ViveVIVE HEALTH LLCILG2023-08-23
00810113570747ViveVIVE HEALTH LLCILG2022-11-28
10810113570744ViveVIVE HEALTH LLCILG2022-11-28
00818323023503Vive VIVE HEALTH LLCILG2022-10-03
00818323023510Vive VIVE HEALTH LLCILG2022-10-03
10818323023500Vive VIVE HEALTH LLCILG2022-10-03
10818323023517Vive VIVE HEALTH LLCILG2022-10-03
10192253062434CONVERTORSCardinal Health 200, LLCILG2022-09-12
50192253062432CONVERTORSCardinal Health 200, LLCILG2022-09-12
00373317568212AUMSlv Pharmaceuticals LLCILG2022-03-08
00636257031308MEDIMEDI MANUFACTURING, INC.ILG2021-09-07
00636257031315MEDIMEDI MANUFACTURING, INC.ILG2021-09-07
00636257031322MEDIMEDI MANUFACTURING, INC.ILG2021-09-07