FDA.reportPublic FDA data

ALLCARE

Primary DI
00182921000076
Brand
ALLCARE
Company
ALLCARE, INC
Model
PA31261
Catalog number
PA31261
Device description
Yellow Isolation Gown, Universal size, disposable
Published
2022-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
10182921000400PackageGS150In Commercial Distribution
00182921000403PrimaryGS10
00182921000076Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1018292100040010182921000400
00182921000403001829210004031829210004030182921000403
00182921000076001829210000761829210000760182921000076

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
630.830.7487qra@allcaredirect.com

Regulatory Flags#

DUNS number
362187580
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
true
Expiration date on label
false
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
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
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
00182921000267AllCareER600ER6002022-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344223333MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223340MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223357MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223364MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223371MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
D832CT10L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2XXL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2XXL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6S1PlasdentPLASDENT CORPORATIONOEA2026-10-12