FDA.reportPublic FDA data

AllCare

Primary DI
00182921000496
Brand
AllCare
Company
ALLCARE, INC
Model
PL100
Catalog number
PL100
Device description
"UNIVERSAL PILLOW CASE, 21"" x 30"", WHITE"
Published
2022-04-06
Public version status
Update
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
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10182921000493PackageGS1100In Commercial Distribution
00182921000496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1018292100049310182921000493
00182921000496001829210004961829210004960182921000496

GMDN Terms#

Term, Definition table
TermDefinition
Basic pillowcase, reusableA protective envelope for a pillow typically made of a thin textile material intended to create a physical barrier to soiling and cross-contamination. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites. The device is laundered for cleaning, usually at regular intervals. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
630.830.7486qra@allcaredirect.com

Regulatory Flags#

DUNS number
362187580
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10182921000127AllCareAG4412AG44122022-04-06
00182921000656ALLCARECK813 CK813 2022-06-05
00182921000670ALLCARECK613CK6132022-06-05
00182921000618AllCarePL3002022-04-06
00182921000533AllCare, INCPL200PL2002022-04-06
10182921000745ALLCAREPJ13011 PJ13011 2022-12-08
10182921000769ALLCAREPK10011PK100112022-12-08
00182921000403ALLCAREPA31261 PA31261 2022-12-03
00182921000076ALLCAREPA31261 PA31261 2022-12-03
10182921000684ALLCAREEB500BEB500B2022-11-27
10182921000851ALLCAREFS100 FS100 2022-11-27
10182921000868ALLCAREEF600PEF600P2022-11-27
10182921000875ALLCAREEF700EF7002022-11-27
00182921000397AllCareEF601XEF601X2022-11-27
00182921000885AllCareEF601XEF601X2022-11-27
00182921000687ALLCAREEB500BEB500B2022-11-27
00182921000854ALLCAREFS100 FS100 2022-11-27
00182921000861ALLCAREEF600PEF600P2022-11-27
00182921000878ALLCAREEF700EF7002022-11-27
00182921000793AllCareER600ER6002022-10-16

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