FDA.reportPublic FDA data

Devon

Primary DI
20884521215013
Brand
Devon
Company
Cardinal Health, Inc.
Model
31404851
Catalog number
31404851
Device description
7382-0T02 Birthday Kit
Published
2017-05-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10884521215016PackageGS118In Commercial Distribution
20884521215013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452121501610884521215016
2088452121501320884521215013

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No;

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
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521012301Monoject118030077711803007772016-09-24
10884521018266Monoject897089702016-09-24
10884521022782SharpSafety8512018512012016-09-24
10884521023253Monoject8506SA8506SA2016-09-24
10884521023369Monoject85221R85221R2016-09-24
10884521023482SharpSafety8534SA8534SA2016-09-24
10884521050310Argyle888856080588885608052016-10-06
10884521050747Argyle888856101988885610192016-09-24
10884521050754Argyle888856102788885610272016-09-24
10884521050761Argyle888856103588885610352016-09-24
10884521050778Argyle888856104388885610432016-09-24
10884521050785Argyle888856105088885610502016-09-24
10884521050792Argyle888856106888885610682016-09-24
10884521050808Argyle888856107688885610762016-10-06
10884521050815Argyle888857050788885705072016-09-24
10884521050822Argyle888857051588885705152016-09-24
10884521050839Argyle888857052388885705232016-09-24
10884521050846Argyle888857054988885705492016-09-24
10884521050853Argyle888857055688885705562016-09-24
10884521050877Argyle888857057288885705722016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956461154CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956463721CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956514768CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956531376CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956532861CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956501935CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-16
10198956520073CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-16
10198956505414CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-09
10198956527492CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-09
10198956491045CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-06
10198956492134CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-06
10198956507449CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-06
10198956496804CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-08
10198956482128CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-05
10198956494879CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-05
10198956495593CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-05
10198956499898CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-05
10198956502215CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-05
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
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10193489215649Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
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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