FDA.reportPublic FDA data

CONVERTORS

Primary DI
20885380018456
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
3201PG
Catalog number
3201PG
Device description
Blue Procedure Gown; X-Large; Blue
Published
2018-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
50885380018457PackageGS16In Commercial Distribution
20885380018456PrimaryGS10
10885380018459Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538001845750885380018457
2088538001845620885380018456
1088538001845910885380018459

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.

Regulatory Flags#

DUNS number
961027315
Device count
10
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40080196772026MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-03
00199536901001BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901018BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901308BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901315BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901407BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901414BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901421BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901438BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901445BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901452BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901469BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901476BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00842942017506PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
00842942017513PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
00842942015700PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942015717PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017261PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017278PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942007934PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942008047PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009570PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009587PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014406PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014420PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942015298PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942015427PRIMEDpriMED Medical Products IncOEA2025-07-15
20885380151511CARDINAL HEALTHCARDINAL HEALTH 200, LLCOEA2025-03-22