FDA.reportPublic FDA data

MEDLINE

Primary DI
30197344036312
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
NONTH310
Catalog number
NONTH310
Device description
PE GOWN, OVRHD, THUMBLOOP, LVL 3, UNIV
Published
2024-08-13
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QPCGown, non-sterile, non-isolation, intended to provide moderate or high barrier protection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier ProtectionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344036315PackageGS115In Commercial Distribution
30197344036312PackageGS15In Commercial Distribution
10197344036318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734403631520197344036315
3019734403631230197344036312
1019734403631810197344036318

GMDN Terms#

Term, Definition table
TermDefinition
Professional examination gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00General warehouse storage conditions, out of direct sunlight.

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
10193489086331MEDLINEMDS9082111MDS90821112026-08-27
10197344011858HUDSON RCIHUD1695HUD16952026-08-27
10197344011865HUDSON RCIHUD1694HUD16942026-08-27
10197344011872HUDSON RCIHUD1693HUD16932026-08-27
10197344011889HUDSON RCIHUD1692HUD16922026-08-27
10197344011896HUDSON RCIHUD1691HUD16912026-08-27
10197344011902HUDSON RCIHUD1690HUD16902026-08-27
10197344011919HUDSON RCIHUD1689HUD16892026-08-27
10197344011926HUDSON RCIHUD1688HUD16882026-08-27
10197344011933HUDSON RCIHUD1687HUD16872026-08-27
10197344011940HUDSON RCIHUD1686HUD16862026-08-27
10197344011957HUDSON RCIHUD1685HUD16852026-08-27
10197344011964HUDSON RCIHUD1683HUD16832026-08-27
10197344016884HUDSON RCIHUD2701LHUD2701L2026-08-27
10197344016891HUDSON RCIHUD2701MHUD2701M2026-08-27
10197344016938HUDSON RCIHUD2701SHUD2701S2026-08-27
10197344016945HUDSON RCIHUD2701XLHUD2701XL2026-08-27
10197344016969HUDSON RCIHUD2702HUD27022026-08-27
10197344016976HUDSON RCIHUD2703HUD27032026-08-27
10197344016983HUDSON RCIHUD2704HUD27042026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10326053121491Regard™Resource Optimization & Innovation, L.L.C.QPC2024-11-28
10326053121507Regard™Resource Optimization & Innovation, L.L.C.QPC2024-11-28
10326053121514Regard™Resource Optimization & Innovation, L.L.C.QPC2024-11-28
20326053121498Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
20326053121504Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
20326053121511Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
10197344036301MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-09-02
20197344036308MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-09-02
10197344036318MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
10197344036325MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
30197344036329MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
00612899045484EncompassEncompass Group, L.L.C.QPC2023-06-22
00612899101104EncompassEncompass Group, L.L.C.QPC2023-06-22
20860005250039ProtectXThe Azac GroupQPC2022-04-07
20860005250060ProtectXThe Azac GroupQPC2022-04-07
20192253003816CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
20192253003823CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
20192253003830CARDINAL HEALTHCARDINAL HEALTH 200, LLCQPC2019-05-10
20192253003847CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
20192253003854CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
50192253003817CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
50192253003824CARDINAL HEALTHCARDINAL HEALTH 200, LLCQPC2019-05-10
50192253003831CARDINAL HEALTHCARDINAL HEALTH 200, LLCQPC2019-05-10
50192253003848CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
50192253003855CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10