FDA.reportPublic FDA data

Abena

Primary DI
06971004783074
Brand
Abena
Company
ABENA NORTH AMERICA, INC.
Model
1000020770
Device description
Isolation Gown - Level 2 - PP + PE (Yellow) Size L
Published
2020-08-26
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

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
06971004783074PackageGS110In Commercial Distribution
06971004783067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971004783074069710047830746971004783074
06971004783067069710047830676971004783067

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
078740398
Device count
1
DM exempt
false
Premarket exempt
false
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
05713571000731Abena10000213152022-08-09
05703538446153Abena10000208642022-08-08
05703538457869Abena19999053542022-08-08
05703538458460Abena19999053752022-08-08
05703538458613Abena19999053762022-08-08
05703538458675Abena19999053782022-08-08
05713571000014Abena10000212792022-08-08
05713571000038Abena10000212802022-08-08
05713571000052Abena10000212812022-08-08
05713571000076Abena10000212822022-08-08
05713571000090Abena10000212832022-08-08
05713571000113Abena10000212842022-08-08
05713571000137Abena10000212852022-08-08
05713571000151Abena10000212862022-08-08
05713571000175Abena10000212872022-08-08
05713571000199Abena10000212882022-08-08
05713571000212Abena10000212892022-08-08
05713571000236Abena10000212902022-08-08
05713571000250Abena10000212912022-08-08
05713571000274Abena10000212922022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196163885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110003MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110010MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110072MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
00634916797114Reusable Gown STANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797121Reusable GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797459ComPel Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881356Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881363Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
10810132044356HCSConcordance Healthcare Solutions LLCOEA2026-03-09
20810132044360HCS SourcingConcordance Healthcare Solutions LLCOEA2026-03-09
40080196765523MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-05
10197344158881MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158904MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158928MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158942MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158966MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158997MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159000MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159024MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159031MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159048MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159055MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159062MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159079MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159086MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159093MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159116MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159123MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344200474MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03