FDA.reportPublic FDA data

Medline

Primary DI
40888277563880
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
SVI-1050
Catalog number
SVI-1050
Device description
DRAPE MRI PATIENT
Published
2021-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKKSUDAN IV

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKKSudan IvHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277563880PackageGS120In Commercial Distribution
10888277563889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827756388040888277563880
1088827756388910888277563889

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
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
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11
10812564036381MedlineSYN3872SYN38722026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841336101012Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336108813Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336108998Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336114630Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336108810Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336108995Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336114637Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00840216101784ASP Medical Asp Global, LLCKKK2022-08-02
10840216101781ASP Medical Asp Global, LLCKKK2022-08-02
10634916809401Side DrapeSTANDARD TEXTILE CO., INC.KKK2021-06-11
10888277563889MedlineMEDLINE INDUSTRIES, INC.KKK2021-02-05
10080196895410MedlineMEDLINE INDUSTRIES, INC.KKK2021-01-26
10080196747924MedlineMEDLINE INDUSTRIES, INC.KKK2020-12-17
00851354004264Sterile DrapeAVINGER, INC.KKK2019-03-21
20845225012698DIGITAL IVUS STERILE EQUIPEMENT COVERVOLCANO CORPORATIONKKK2017-03-02
10080196308200MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
10080196722938MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
10080196915033MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
40080196308201MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
00801902081490ARROWTELEFLEX INCORPORATEDKKK2016-09-16
30801902081491ARROWTELEFLEX INCORPORATEDKKK2016-09-16
20845225012681SpinVision STERILE EQUIPEMENT COVERVOLCANO CORPORATIONKKK2016-09-08
10845225012707R-100 STERILE EQUIPMENT COVERPhilips Image Guided Therapy CorporationKKK2016-09-08
10885380064234CONVERTORSCardinal Health 200, LLCKKK2016-06-28
50885380064232CONVERTORSCardinal Health 200, LLCKKK2016-06-28