BIOTRANS™ Pressure Monitoring Kits

Basic Information

• Brand Name: BIOTRANS™ Pressure Monitoring Kits
• Primary DI: 08888893311562
• Version / Model: 91065 NICU KIT - CHILDREN'S MERCY HOSPI
• Catalog Number: 22-000910-65
• Company Name: BIOPTIMAL INTERNATIONAL PTE. LTD.
• Labeler DUNS: 595182247
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 6
• Public Version Date: 2020-12-01
• Public Version Status: Update
• Public Device Record Key: abdc383b-2c73-4a7b-aa63-06d358f0944d
• Distribution End Date: 2020-12-01

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: No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	870.2850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45275	Invasive blood pressure transducer set	A collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	98888893311565	GS1	CTN	9	Not in Commercial Distribution	2020-12-01
Package	28888893311566	GS1	BOX	10	Not in Commercial Distribution	2020-12-01
Primary	08888893311562	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark cool dry places