BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes 368494

GUDID 50382903684941

TUBE LIHEP PLH 13X75 2.0 PLCE GN

Becton, Dickinson U.K. Limited

Evacuated blood collection tube IVD, anticoagulant

Primary Device ID	50382903684941
NIH Device Record Key	82d226f0-24b7-4e3e-8f3e-87e80b4373e1
Commercial Distribution Status	In Commercial Distribution
Brand Name	BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes
Version Model Number	368494
Catalog Number	368494
Company DUNS	225931062
Company Name	Becton, Dickinson U.K. Limited
Device Count	100
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903684946 [Unit of Use]
GS1	30382903684947 [Primary]
GS1	50382903684941 [Package] Contains: 30382903684947 Package: Case [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K901449

FDA Product Code

JKA	Tubes, vials, systems, serum separators, blood collection

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-04-12
Device Publish Date	2024-04-04

Devices Manufactured by Becton, Dickinson U.K. Limited

00382903660162 - BD Seditainer™ Stand	2024-04-26 ESR SEDITAINER TUBE STAND FOR 10 TUBES
50382903688864 - BD Vacutainer® LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes	2024-04-16 TUBE LIHEP PLH 13X100 6.0 PLBLCE GN
50382903684941 - BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes	2024-04-12TUBE LIHEP PLH 13X75 2.0 PLCE GN
50382903684941 - BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes	2024-04-12 TUBE LIHEP PLH 13X75 2.0 PLCE GN
50382903685016 - BD Vacutainer® Z (No Additive) Plus Urine Tube	2024-04-12 TUBE URIN PLH 13X100 6.0 UA TAN
50382903688840 - BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes	2024-04-12 TUBE LIHEP PLH 13X75 4.0 PLBLCE GN
00382903643783 - BD A-Line™ Arterial Blood Collection Syringe	2024-04-10 SYR ABG ALINE 3(1) LL CE
00382903643899 - BD Preset™ Eclipse™ Arterial Blood Collection Syringe	2024-04-10 SYR ABG PRESET 3(1.6) 22X1.25 ECLIPSE CE
00382903643905 - BD Preset™ Eclipse™ Arterial Blood Collection Syringe	2024-04-10 SYR ABG PRESET 3(1.6) LL 22X1 ECLIPSE CE

Trademark Results [BD Vacutainer]

Mark Image Registration \| Serial	Company Trademark Application Date
BD VACUTAINER 78264506 2858038 Live/Registered	Becton, Dickinson and Company 2003-06-19
BD VACUTAINER 77000481 3257557 Dead/Cancelled	Becton, Dickinson and Company 2006-09-15