CORD STICK

Primary DI
0861916000304
Brand
CORD STICK
Company
CORD STICK CORPORATION
Model
MULTIPLE DRAW SYSTEM
Catalog number
2003-001
Device description
The Cord Stick Multiple Draw System is indicated for collection of blood from the umbilical cord after delivery of a new born infant. The blood is for
Published
2016-09-23
Public version status
Update
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
KNAInstrument, Manual, Specialized Obstetric-Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNAInstrument, Manual, Specialized Obstetric-GynecologicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031058000CORD STICK MULTIPLE DRAW SYSTEMCord Stick Corp.2003-06-13FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
0861916000304PackageGS116In Commercial Distribution
40861916000304PrimaryGS10
00861916000304Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
0861916000304008619160003048619160003040861916000304
4086191600030440861916000304

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of sterile devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-830-9118REGARDEZ@CORDSTICK.COM

Regulatory Flags#

DUNS number
053371576
Device count
16
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00861916000306CORD STICK MULTIPLE DRAW SYSTEM2003-0012016-09-23
0861916000307CORD STICK MULTIPLE DRAW SYSTEM2003-0012016-09-23

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