FDA.reportPublic FDA data

MDHC

Primary DI
06974669350216
Brand
MDHC
Company
MDHC Life Technologies (Kunshan) Co., LTD.
Model
1 pcs
Device description
Isolation gown
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
06974669350216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974669350216069746693502166974669350216

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
625685749
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974669350292MDHC20 pcs/bag2023-07-06
06974669350193MDHC5 pcs2023-07-06
06974669350209MDHC1 pair2023-07-06
06974669350223MDHC10 pcs2023-07-06
06974669350230MDHC1 pcs/box2023-07-06
06974669350247MDHC5 units/case2023-07-06
06974669350254MDHC250 tips/box2023-07-06
06974669350261MDHC5 pcs/bag2023-07-06
06974669350278MDHC10 pcs/box2023-07-06
06974669350285MDHC5 pcs/bag2023-07-06
06974669350308MDHC1 pcs/bag2023-07-06
06974669350315MDHC6 pcs/box2023-07-06
06974669350322MDHC5 pcs/bag2023-07-06
06974669350339MDHC12 pcs/Case2023-07-06
06974669350346MDHC50 serving/box2023-07-06
06974669350353MDHC1 set/bag2023-07-06
06974669350360MDHC1 set/bag2023-07-06
06974669350377MDHC5 pcs/bag2023-07-06
06974669350384MDHC5 pcs/bag2023-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10197106988251CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-19
10197106988176CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-13
20885380151511CARDINAL HEALTHCARDINAL HEALTH 200, LLCOEA2025-03-22
10197106824832CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106860120CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106873113CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-18
10197106861936CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106868249CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106779781CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106810477CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106835029CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-19
10197106835128CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-18
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106746011CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106829097CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106818862CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-05
10197106820759CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-29
10197106741979CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-11
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106796115CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106744192CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26