FDA.reportPublic FDA data

212NY

Primary DI
00860013168926
Brand
212NY
Company
Two One Two New York, Inc.
Model
27000XL
Catalog number
27000XL
Device description
LEVEL 2 DISPOSABLE ISOLATION GOWN - 10 PACK
Published
2024-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Gown

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013168933PackageGS110In Commercial Distribution
00860013168926PrimaryGS10
10860013168923Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013168933008600131689338600131689330860013168933
00860013168926008600131689268600131689260860013168926
1086001316892310860013168923

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.

Contacts#

Phone, Email table
PhoneEmail
212-840-8665health@212nyusa.com

Regulatory Flags#

DUNS number
047786285
Device count
10
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013168902212NY27000L27000L2024-11-25
00860013168919212NY27000L27000L2024-11-25
10860013168923212NY27000XL27000XL2024-11-25
G33527000L1212NY27000270002022-11-14
G33527000XL1212NY27000270002022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13