FDA.reportPublic FDA data

Kendall

Primary DI
10884521148345
Brand
Kendall
Company
Cardinal Health, Inc.
Model
22660A
Catalog number
22660A
Device description
Cable and Lead Wire Accessory, Adapter Clip
Published
2017-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942321000VARIOUSPATIENT MONITORING CABLEMerit Cables Incorporated1994-11-04DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521148345PackageGS1250In Commercial Distribution
20884521148342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452114834510884521148345
2088452114834220884521148342

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module rackA device typically designed as a framework or specially constructed holder where module devices used with a patient monitoring system can be plugged in and connected to the parent device usually by one cable. This device is typically used to facilitate connection to the patient from the modules using standard length cables and leads when the parent device is situated away from the patient (out of reach), e.g., the parent device may be mounted to a wall support or a ceiling pendant arm (Utility supply system).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00none;

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
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
20884521100401SharpSafety8602U8602U2016-09-24
10884527004676Argyle43309433092016-10-14
10884527005079Argyle43201432012016-09-24
10884527005086Argyle1604091604092016-09-24
10884527005147Argyle888816040888881604082016-09-24
10884527005215Argyle888816083888881608382016-09-24
10884527005222Argyle888816085388881608532016-09-24
20884527004680Argyle43311433112016-09-24
20884527020543Argyle888816044088881604402016-09-24
20884527020550Argyle888816045788881604572016-09-24
20884521012193Monoject888153576288815357622016-09-24
10884521022966Monoject8989PG28989PG22016-09-24
30884521019229SharpSafety882088202016-09-24
40884521022936Monoject8939PG28939PG22016-09-24
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-10-28
04719872982296QT ECGQt Medical, Inc.DSA2026-10-28
04719872982302QT ECGQt Medical, Inc.DSA2026-10-28
04719872982418QT ECGQt Medical, Inc.DSA2026-10-28
06946725572924APKAPK Technology Co.,Ltd.DSA2026-10-26
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607413FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607420FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607437FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607444FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
G662ME590221F1MaguireMaguire Enterprises, Inc.DSA2026-10-19
G662ME590303G1MaguireMaguire Enterprises, Inc.DSA2026-10-16
00195278840202MACGe Medical Systems Information Technologies, Inc.DSA2026-10-13
06946725572139APKAPK Technology Co.,Ltd.DSA2026-10-13
042504134004853-channel ECG ElectrodeSOMNOmedics AGDSA2026-10-09
G662ME3311MaguireMaguire Enterprises, Inc.DSA2026-10-09
G662ME3381MaguireMaguire Enterprises, Inc.DSA2026-10-09
00840416607345FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607352FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607369FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607376FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607383FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607390FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25