FDA.reportPublic FDA data

Devon

Primary DI
10884527015535
Brand
Devon
Company
Cardinal Health, Inc.
Model
52000015
Catalog number
52000015
Device description
7335 C-Section Plus Kit
Published
2017-04-21
Public version status
Update
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
MLSLabor and Delivery Kit

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961993000BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)Devon Industries, Inc.1996-07-03MLS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884527015535PackageGS14In Commercial Distribution
20884527015532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452701553510884527015535
2088452701553220884527015532

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30884527004847KendallES82417ES824172016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24
10884521154100Devon31146895311468952016-09-24
10192253059984Dover7014MF7014MF2022-06-07
10884521013230Monoject888122524188812252412016-09-24
10884521013254Monoject888122524588812252452016-09-24
10884521024854Kendall923892382018-06-27
10884521004498Dover1455001455002016-09-24
10884521014091Monoject888150164088815016402016-09-24
10884521163041Magellan888185005888818500582016-09-24
10884527021932Uni-PatchEP84580EP845802016-09-24
20884521012216Monoject888153578888815357882016-09-24
20884521012254Monoject888156018288815601822016-09-24
20884521014159Monoject888151613588815161352016-10-13
10884521518889Kangaroo888472109688847210962016-09-24
10884521015791Dover888762312588876231252016-09-24
10884521015920Dover20512C20512C2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956448148CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-01
10198956481848CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-01
10198956489400CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-01
10198956491137CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-01
10198956492448CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-01
10193489215052Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489215649Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489410006Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489412673Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489414646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489415773Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489417289Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489418187Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419214Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419290Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419429Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489423730Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489424089Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489426229Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489426410Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489430202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489443288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489446159Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489447286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489454598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489454666Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489455946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489456899Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489459319Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10080196849710Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2022-11-24