FDA.reportPublic FDA data

Essential Cares

Primary DI
00850018936217
Brand
Essential Cares
Company
Essential Cares Supplies, Inc.
Model
JBCPAFBC1024BES
Catalog number
JBCPAFBC1024BES
Device description
Bouffant Cap Blue 24in 100Pc/Bg 10Bg/Cs
Published
2023-03-17
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
FYFCap, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018936217PackageGS110In Commercial Distribution
00850018936200PrimaryGS10
10850018936207Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018936217008500189362178500189362170850018936217
00850018936200008500189362008500189362000850018936200
1085001893620710850018936207

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2137431402info@essentialcares.com

Regulatory Flags#

DUNS number
809399350
Device count
100
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
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

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Primary DI, Brand, Company table
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00840456217573JMUJMU DENTAL, INCFYF2026-07-07
00199536901100BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901117BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901124BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901131BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901148BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901155BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901162BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
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20197344202215MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
20680651497271HalyardO&M HALYARD, INC.FYF2025-10-24
00813360021512ProtexerICP MEDICAL, LLCFYF2025-08-19
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