Jelco

Basic Information

• Brand Name: Jelco
• Primary DI: 10351688007957
• Version / Model: 4142
• Company Name: SMITHS MEDICAL ASD, INC.
• Labeler DUNS: 137835299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2017-01-17
• Public Version: 6
• Public Version Date: 2019-04-23
• Public Version Status: Update
• Public Device Record Key: 2895ab65-6f0b-4b09-b81d-75bc1c321cd3

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKA	Tubes, vials, systems, serum separators, blood collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37566	Blood collection tube holder, single-use	A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30351688007951	GS1	CASE	5	In Commercial Distribution
Primary	10351688007957	GS1
Unit of Use	20351688007954	GS1

Premarket Submissions

Submission Number	Supplement Number
K922445	000