FDA.reportPublic FDA data

DMI

Primary DI
10041298803024
Brand
DMI
Company
D-M-S HOLDINGS, INC.
Model
532-8035-0100
Device description
Gown Convalescent W/Ties Blue 12/pk
Published
2025-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041298803024PackageGS110In Commercial Distribution
00041298803027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004129880302410041298803024
00041298803027000412988030270412988030270041298803027

GMDN Terms#

Term, Definition table
TermDefinition
Patient gown, reusableA garment made of natural and/or synthetic materials (e.g., cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and is closed by ties at the back/side of the garment. This is a reusable garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062028220
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041298995326DMI619-5140-19002026-06-05
00767056160026MABIS01-160-02101-160-0212016-09-23
00767056160088MABIS01-160-08101-160-0812016-09-23
00767056160156MABIS01-160-15101-160-1512016-09-23
00767056160200MABIS01-160-20101-160-2012016-09-23
00767056160217MABIS01-160-21101-160-2112016-09-23
00767056160248MABIS01-160-24101-160-2412016-09-23
00767056410176MABIS09-141-01709-141-0172016-09-23
00767056110212MABIS01-110-02101-110-0212016-09-23
00767056234017MABIS05-234-01005-234-0102016-09-23
00767056300118MABIS01-130-01101-130-0112016-09-23
00767056300156MABIS01-130-01501-130-0152016-09-23
00767056300163MABIS01-130-01601-130-0162016-09-23
00767056322059MABIS05-223-06005-223-0602016-09-23
00767056400115MABIS01-140-01101-140-0112016-09-23
00767056400139MABIS01-140-01301-140-0132016-09-23
00767056400153MABIS01-140-01501-140-0152016-09-23
00767056400160MABIS01-140-01601-140-0162016-09-23
00767056400177MABIS01-140-01701-140-0172016-09-23
00767056550117MABIS01-155-01101-155-0112016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344223388MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-29
20197344223333MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223340MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223357MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223364MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223371MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
D832CT10L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2XXL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2XXL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6M1PlasdentPLASDENT CORPORATIONOEA2026-10-12