FDA.reportPublic FDA data

Essential Cares

Primary DI
00850018936507
Brand
Essential Cares
Company
Essential Cares Supplies, Inc.
Model
MLCTWTKCCNP-XXL-ES
Catalog number
MLCTWTKCCNP-XXL-ES
Device description
Lab Coat SMS White Knit Cuff Knit Collar No Pocket XX-Large Essential Cares 10pc/Bg 3Bg/Cs
Published
2023-05-26
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

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
00850018936507PackageGS13In Commercial Distribution
00850018936408PrimaryGS10
10850018936382Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018936507008500189365078500189365070850018936507
00850018936408008500189364088500189364080850018936408
1085001893638210850018936382

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2137431402info@essentialcares.com

Regulatory Flags#

DUNS number
809399350
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018936712Essential CaresMGWNISOSPP20ECYLESMGWNISOSPP20ECYLES2023-03-17
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
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

Other Devices Sharing Product Codes#

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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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
00842942016530PRIMEDpriMED Medical Products IncOEA2025-07-21
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