FDA.reportPublic FDA data

carePAC

Primary DI
10850003042432
Brand
carePAC
Company
Extremity Care
Model
CS-MB01
Device description
carePAC Standard Size, Collagen Matrix w/ Bordered Fiber Gelling Gauze Single Kit contains: CP002 - 2x2 Collagen Matrix with Primary DI: 30612553024290 or 00366977310222 CP005 - Fiber Gell Dressing 4x4 Bordered with Primary DI: 4052199515137 CP009 - Conforming Stretch Bandage 4inx4.1yds with Primary DI: 10612553016222 or 10612553013221 CP000 - Gloves
Published
2024-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10850003042432PackageGS130In Commercial Distribution
00850003042435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000304243210850003042432
00850003042435008500030424358500030424350850003042435

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
1-888-694-6694customerservice@extremitycare.com

Regulatory Flags#

DUNS number
086365085
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

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
00850003042466carePACCX-PB012024-02-06
00850003042329careLAGEN EC0112023-07-19
00850003042312Paper Surgical TapeEC0012023-04-21
00850003042305Extremity CareATL100S2023-03-30

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