FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489190052
Brand
MEDLINE
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
EBSI1325
Catalog number
EBSI1325
Device description
CHOP NICU KIT
Published
2020-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489190059PackageGS120In Commercial Distribution
10193489190052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348919005920193489190059
1019348919005210193489190052

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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 single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160394068CENTURIONSUT11035ASUT11035A2026-07-21
10653160239369CENTURIONCHT805CHT8052022-01-01
10653160243694CENTURIONSUT17770SUT177702022-01-02
10653160277859CENTURIONSUT19145SUT191452022-01-02
10653160283966CENTURIONCVI4145CVI41452017-08-14
10653160285267CENTURIONMNS9625MNS96252022-01-02
10653160317937CENTURIONTRI66800TRI668002022-01-02
10653160322948CENTURIONSUT20915SUT209152022-01-02
10653160330783CENTURIONSUT21230ASUT21230A2022-01-02
10653160333883CENTURIONSUT18765ASUT18765A2022-01-02
10653160345220CENTURIONMNS13075MNS130752022-01-01
10653160360247CENTURIONMNS7285AMNS7285A2023-05-22
10653160374183CENTURIONMNS11780BMNS11780B2024-05-02
00653160013641CENTURIONMNS1080MNS10802022-01-01
00653160017762CENTURIONUVT235UVT2352022-01-02
00653160191349CENTURIONMNS5555MNS55552022-01-01
00653160199352CENTURIONSUT1243ASUT1243A2022-01-02
00653160200867CENTURIONSUT15260SUT152602022-01-02
00653160228397CENTURIONSUT17155SUT171552022-01-02
00653160130683Centurion589784ST589784ST2022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160393979MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394051MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394082MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394112MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394129MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394181MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10653160394211MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-07-21
10198956334281CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-20
10198956500518CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-20
10198956504097CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-20
10198956481251CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-16
10198956524590CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-16
10198956481312CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-09
10198956518995CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-09
10198956519176CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-09
10809160526866MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OXQ2026-07-08
10198956520233CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-06
10198956520547CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-06
10198956481282CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-23
10198956481305CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-23
10653160394037MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-06-22
10653160393764MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-06-10
10653160393849MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-06-10
10198956477278CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-08
10198956487765CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-05
10198956428942CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10198956476639CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10198956479852CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10653160393726MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-05-27
10653160393733MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-05-27