FDA.reportPublic FDA data

Essential Cares

Primary DI
00850018936712
Brand
Essential Cares
Company
Essential Cares Supplies, Inc.
Model
MGWNISOSPP20ECYLES
Catalog number
MGWNISOSPP20ECYLES
Device description
Isolation Gown NW SPP Elastic Cuff Tie Back/Waist Yellow X-Large Essential Cares 10Pc/Bg 5Bg/Cs
Published
2023-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
10850018936719PackageGS15In Commercial Distribution
00850018936712PrimaryGS10
20850018936716Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001893671910850018936719
00850018936712008500189367128500189367120850018936712
2085001893671620850018936716

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
2137431402info@essentialcares.com

Regulatory Flags#

DUNS number
809399350
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018936408Essential CaresMLCTWTKCCNP-XXL-ESMLCTWTKCCNP-XXL-ES2023-05-26
00850018936897Essential CaresMLCTWTKCCNP-5XL-ESMLCTWTKCCNP-5XL-ES2023-05-26
00850018936910Essential CaresMLCTBLKCCNP-S-ESMLCTBLKCCNP-S-ES2023-05-26
00850018936934Essential CaresMLCTBLKCCNP-M-ESMLCTBLKCCNP-M-ES2023-05-26
00850018936958Essential CaresMLCTBLKCCNP-L-ESMLCTBLKCCNP-L-ES2023-05-26
00850018936972Essential CaresMLCTBLKCCNP-XL-ESMLCTBLKCCNP-XL-ES2023-05-26
00850018936996Essential CaresMLCTBLKCCNP-XXL-ESMLCTBLKCCNP-XXL-ES2023-05-26
00850051455010Essential CaresMLCTBLKCCNP-XXXL-ESMLCTBLKCCNP-XXXL-ES2023-05-26
00850051455034Essential CaresMLCTBLKCCNP-XXXXL-ESMLCTBLKCCNP-XXXXL-ES2023-05-26
00850051455058Essential CaresMLCTBLKCCNP-5XL-ESMLCTBLKCCNP-5XL-ES2023-05-26
00850018936507Essential CaresMLCTWTKCCNP-XXL-ESMLCTWTKCCNP-XXL-ES2023-05-26
00850018936903Essential CaresMLCTWTKCCNP-5XL-ESMLCTWTKCCNP-5XL-ES2023-05-26
00850018936927Essential CaresMLCTBLKCCNP-S-ESMLCTBLKCCNP-S-ES2023-05-26
00850018936941Essential CaresMLCTBLKCCNP-M-ESMLCTBLKCCNP-M-ES2023-05-26
00850018936965Essential CaresMLCTBLKCCNP-L-ESMLCTBLKCCNP-L-ES2023-05-26
00850018936989Essential CaresMLCTBLKCCNP-XL-ESMLCTBLKCCNP-XL-ES2023-05-26
00850051455027Essential CaresMLCTBLKCCNP-XXXL-ESMLCTBLKCCNP-XXXL-ES2023-05-26
00850051455041Essential CaresMLCTBLKCCNP-XXXXL-ESMLCTBLKCCNP-XXXXL-ES2023-05-26
00850018936361Essential CaresMLCTWTKCCNP-L-ESMLCTWTKCCNP-L-ES2023-03-30
00850018936378Essential CaresMLCTWTKCCNP-M-ESMLCTWTKCCNP-M-ES2023-03-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40884389804637MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
50193489108239MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
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
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