FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
00653160341409
Brand
MEDLINE INDUSTRIES, INC.
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
A4820HKI
Catalog number
A4820HKI
Device description
STD, VAN, 4L, 8.5F, 20CM, HKIC
Published
2020-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160341409PackageGS15In Commercial Distribution
10653160341406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160341409006531603414096531603414090653160341409
1065316034140610653160341406

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of sterile devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160395232CENTURIONCIT6750ACIT6750A2026-10-13
10653160393443CENTURIONDT23110DT231102026-10-08
10653160394075CENTURIONDT21660CDT21660C2026-10-08
10653160393344CENTURIONDM1348DM13482026-10-07
10653160393818CENTURIONDT15200CDT15200C2026-10-07
10653160394464CENTURIONDT12565ADT12565A2026-10-07
10653160320265CENTURIONID1945AID1945A2022-01-01
10653160365815CENTURIONI69005I690052023-09-05
20653160251610CENTURIONFCS300XTFCS300XT2022-01-01
00653160013191CENTURIONHT855HT8552017-08-25
10653160393450CENTURIONCVI5404CVI54042026-10-05
10653160394242CENTURIONCIT7621CIT76212026-10-05
10653160394297CENTURIONCHT1885ACHT1885A2026-10-05
10653160394570CENTURIONCIT2285ACIT2285A2026-10-05
10653160394754CENTURIONCIT5165ACIT5165A2026-10-05
10653160394785CENTURIONCIT5350ACIT5350A2026-10-05
10653160394808CENTURIONCIT4660ACIT4660A2026-10-05
10653160328131CENTURIONDT22125DT221252022-01-01
10653160353461CENTURIONDT21830BDT21830B2022-05-31
10653160381341CENTURIONDM1336DM13362024-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956606203CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-13
10809160540596HalyardAVID MEDICAL, INC.OES2026-10-13
10198956592766CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956597518CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598416CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598522CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598539CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956602311CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956602748CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10809160540145HalyardAVID MEDICAL, INC.OES2026-10-08
10198956593817CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956593930CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956596016CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956598546CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956601062CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10809160539545HalyardAVID MEDICAL, INC.OES2026-10-01
10198956488847CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956516946CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956592308CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956593459CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956596641CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10809160539477HalyardAVID MEDICAL, INC.OES2026-09-30
10198956461963CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-29
10809160539262HalyardAVID MEDICAL, INC.OES2026-09-29
B098AMS194460Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-28
B098DDS1159D0Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-26
10198459754210MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459754524MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755699MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755705MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25