FDA.reportPublic FDA data

ALLCARE

Primary DI
00182921000403
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
OTC
true
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

Contacts#

Phone, Email table
PhoneEmail
630.830.7487qra@allcaredirect.com

Regulatory Flags#

DUNS number
362187580
Device count
10
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
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
00182921000267AllCareER600ER6002022-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
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10198956101425CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-10
10198956102163CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-10
10198956099128CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
10198956101746CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
10198956101401CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-05
10198956101906CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-05
10198956089303CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-22
10197106988251CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-19
10198956089143CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-14
10197106988176CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-13
10197106824832CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106860120CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106873113CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-18
10197106861936CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106868249CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106779781CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106810477CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106835029CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-19
10197106835128CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-18
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106746011CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13