FDA.reportPublic FDA data

Centurion

Primary DI
50653160060275
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
M2066
Published
2018-10-14
Public version status
New
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
MLSLabor and Delivery Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLSLabor And Delivery KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50653160060275PackageGS120In Commercial Distribution
00653160060270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5065316006027550653160060275
00653160060270006531600602706531600602700653160060270

GMDN Terms#

Term, Definition table
TermDefinition
Visitor hygiene clothing kitA collection of non-sterile apparel intended to be worn by a visitor to a healthcare facility as temporary clean clothing when with patients in non-sterile environments that may require a higher level of hygiene than a normal patient ward [e.g., intensive care unit (ICU), postoperative recovery ward]. It typically consists of a cap, scrub suit (shirt and pants), shoe covers, gown, and face mask composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between the visitor and patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)248-4058CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
false
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
10653160251729CENTURIONMNS7810MNS78102022-01-01
10653160254799CENTURIONCHT890CHT8902022-01-01
10653160257028CENTURIONSUT18270SUT182702022-01-02
10653160257417CENTURIONCIT5460CIT54602016-09-05
10653160279068CENTURIONSUT19360SUT193602022-01-02
10653160291060CENTURIONMNS9970MNS99702022-01-02
10653160292029CENTURIONMNS9715MNS97152022-01-02
10653160292562CENTURIONMNS9820MNS98202022-01-02
10653160293798CENTURIONIV8310EIV8310E2017-08-18
10653160310006CENTURIONID2060ID20602021-11-29
10653160313243CENTURIONSUT20670SUT206702022-01-02
10653160313823CENTURIONSUT20685SUT206852022-01-02
10653160316626CENTURIONMNS11230MNS112302018-05-03
10653160317210CENTURIONTC7955TC79552022-01-02
10653160318170CENTURIONOR2050OR20502022-01-02
10653160318361CENTURIONMNS11280MNS112802022-01-01
10653160319160CENTURIONIV8675IV86752018-07-16
10653160323211CENTURIONMNS11745MNS117452022-01-01
10653160324065CENTURIONMNS11760MNS117602022-01-01
10653160325000CENTURIONCIT6905CIT69052022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956514485CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956575363CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956585546CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956585553CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956543638CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956555372CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956563742CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956579675CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956504158CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571648CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571891CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956572966CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956549685CARDINAL HEALTHCardinal Health 200, LLCMLS2026-08-18
10198956555167CARDINAL HEALTHCardinal Health 200, LLCMLS2026-08-17
10198956541337CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-31
10809160527894HalyardAVID MEDICAL, INC.MLS2026-07-28
10809160527900HalyardAVID MEDICAL, INC.MLS2026-07-28
10198956412262CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956467903CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956483996CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956495883CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956511453CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956514065CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956527935CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956534766CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956535312CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956536289CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956537026CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956461154CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956463721CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20