FDA.reportPublic FDA data

Centurion

Primary DI
00653160317602
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
DT21410
Catalog number
DT21410
Device description
BARRIER CENTRAL LINE KIT
Published
2022-01-01
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
FYEDRESS, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYEDress, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160317602PackageGS110In Commercial Distribution
10653160317609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160317602006531603176026531603176020653160317602
1065316031760910653160317609

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). 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
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393757CENTURIONCIT5215ACIT5215A2026-05-27
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810100050313KBMEDKB Medical (group), Inc.FYE2025-05-22
00810100050320KBMEDKB Medical (group), Inc.FYE2025-05-22
00810100050337KBMEDKB Medical (group), Inc.FYE2025-05-22
00810100050344KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050310KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050327KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050334KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050341KBMEDKB Medical (group), Inc.FYE2025-05-22
10097604601129Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
10097604603345Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
00097604601122Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
00097604603348Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
06970645860113YINGJIAJiangsu Jiawen Medical Supplies Co.,Ltd.FYE2022-10-20
10732224000920Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
10732224000944Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000935Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000959Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000928Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000942Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
00732224000930Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
00732224000954Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
10889950134136Crosstex™HU-FRIEDY MFG. CO., LLCFYE2022-03-11
00813360021390ProtexerICP MEDICAL, LLCFYE2022-02-03
10813360021397ProtexerICP MEDICAL, LLCFYE2022-02-03
10653160317609CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFYE2022-01-01
10653160217626Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.FYE2021-09-02
40653160217627Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.FYE2021-09-02
B086105051Protect U Guard CPE Isolation GownPROTECT U GUARD, LLCFYE2021-02-02
06944414040914MED-LINKShenzhen Med-Link Electronics Tech Co.,Ltd.FYE2020-05-07
10603295326359LIFE LINERDEPUY ORTHOPAEDICS, INC.FYE2018-09-24