FDA.reportPublic FDA data

carePAC

Primary DI
00850003042466
Brand
carePAC
Company
Extremity Care
Model
CX-PB01
Device description
carePAC Large Size, Collagen Powders w/ Bordered Fiber Gelling GauzeKit contains: CP001 (x2) - 1 g Collagen Powder with Primary DI: 4052199578750 or 00366977311014CP007 - Fiber Gell Dressing 7x7 with Primary DI: 4052199515175 OR CP008 - 8x8 Bordered with Primary DI: 4052199580494 CP010 - Conforming Stretch Bandage 6inx4.1yds with Primary DI: 10612553016239 or 10612553013238 CP000 - Gloves
Published
2024-02-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCYWound Dressing Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCYWound Dressing KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003042466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003042466008500030424668500030424660850003042466

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, medicatedA collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-869-6694customerservice@extremitycare.com

Regulatory Flags#

DUNS number
086365085
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003042169carePACECP-0302023-02-02
00850003042176carePACECD-0302023-02-02
00850003042183carePACECA-0302023-02-02
00850003042190careGARDEC0022023-02-02
00850003042206careLAGENEC0042023-02-02
00850003042213KendallEC0072023-02-02
00850003042220careLAGENEC0082023-02-02
00850003042411carePACCS-MA01 2024-02-06
00850003042428carePACCS-PB012024-02-06
00850003042435carePACCS-MB012024-02-06
00850003042442carePACCS-PN012024-02-06
00850003042459carePACCS-MN012024-02-06
00850003042473carePACCX-MB012024-02-06
00850003042381Extremity CareALC4252024-02-06
00850003042398Extremity CareALC400S2024-02-06
00850003042404carePACCS-PA012024-02-06
00850003042329careLAGEN EC0112023-07-19
00850003042312Paper Surgical TapeEC0012023-04-21
00850003042305Extremity CareATL100S2023-03-30
00850003042237Extremity CareALC100S2023-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459428623MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10198459433474MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10198459171789Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-11-24
10653160381518MEDLINEMEDLINE INDUSTRIES, INC.MCY2024-10-28
10198459057939Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-10-20
10195327657833Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10195327667924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10198459053849Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-06-30
10195327559182Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-12-21
10193489360479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10193489417005Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10193489417043Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10195327421298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10195327297725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-13
10193489398335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489398427Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489399820Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489399929Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489411560Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489416954Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418385Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418392Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418408Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489420982Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489421088Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489421606Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489423600Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489432121Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489432138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08