FDA.reportPublic FDA data

MEDI

Primary DI
00636257050521
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
193S01
Device description
30-40 COMFORT THG BDTB OT NATURAL I S
Published
2024-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWLStocking, medical support (to prevent pooling of blood in legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636257050521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257050521006362570505216362570505210636257050521

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 intended for use in the home or a clinical setting. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
960754430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636257220733MEDIFS124352026-10-12
00636257220740MEDIFS124362026-10-12
00636257220757MEDIFS124372026-10-12
00636257220764MEDIFS124382026-10-12
00636257220771MEDIFS124392026-10-12
00636257220788MEDIFS124402026-10-12
00636257220795MEDIFS124412026-10-12
00636257220801MEDIFS124422026-10-12
00636257220887MEDIFS124432026-10-12
00636257220894MEDIFS124442026-10-12
00636257220900MEDIFS124452026-10-12
00636257220917MEDIFS124462026-10-12
00636257220924MEDIFS124472026-10-12
00636257220931MEDIFS124482026-10-12
00636257220948MEDIFS129352026-10-12
00636257220955MEDIFS129362026-10-12
00636257220962MEDIFS129372026-10-12
00636257220979MEDIFS129382026-10-12
00636257220986MEDIFS129392026-10-12
00636257220993MEDIFS129402026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00674854000013SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000020SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000037SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000044SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000068SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000075SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000082SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000099SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000105SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000112SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000129SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000136SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000143SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000150SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000167SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000174SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000181SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000198SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000204SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000211SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000228SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000235SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000242SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000259SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000266SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000273SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000280SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000297SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000303SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000310SOFT SOCK ®Thuasne LLCDWL2018-12-31