FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942116980
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
P130819
Catalog number
P130819
Device description
BIAS STCKNT 5 KIT
Published
2016-11-07
Public version status
Update
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
DWLStocking, medical support (to prevent pooling of blood in legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112769000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112769000CURAD COMPRESSION HOSIERYMedline Industries, Inc.2012-03-01DWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889942116980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088994211698010889942116980

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10080196180639GeminiGEM1115SGEM1115S2020-12-22
00080196749884MEDLINEMDS149010MDS1490102024-03-05
00080196749891MEDLINEMDS149000MDS1490002021-09-09
10080196418329MEDLINEHCS4482RHCS4482R2021-03-31
10080196418336MEDLINEHCS4483RHCS4483R2020-12-01
10080196715534HUDSON RCIHCS4482HCS44822021-03-31
10080196715565MEDLINEHCS4486HCS44862021-03-31
10888277657625MEDLINEHCSU4483HCSU44832021-10-01
10888277699205MEDLINEHCS4481VTHCS4481VT2021-10-01
10888277699229MEDLINEHCS4483VTHCS4483VT2021-10-01
10888277699236MEDLINE INDUSTRIESHCSU448314HCSU4483142021-10-01
00888277692100MEDLINEHCS4480HCS44802021-05-18
00888277699215MEDLINEHCS448314HCS4483142021-05-18
10080196715541MEDLINEHCS4483HCS44832020-10-28
00888277682033MEDLINEHCSU4482HCSU44822020-08-21
00888277682040MEDLINEHCSU4485HCSU44852020-08-21
10080196259441MedlineMDT013380MDT0133802016-10-14
10080196993819MEDLINEDYND19120DYND191202020-11-12
00080196515939CURADCUR9224CUR92242026-07-06
10197344012039HUDSON RCIHUD1743HUD17432026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00048503515379Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515386Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515393Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515416Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515423Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515430Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515447Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515454Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515461Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515478Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515485Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515492Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515508Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515515Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515522Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515539Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515546Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515553Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00850073571385American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571392American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571415American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571422American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571446American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571453American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571477American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571484American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
G4200211Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4200221Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.DWL2026-06-04