Aligned Medical Solutions

Basic Information

• Brand Name: Aligned Medical Solutions
• Primary DI: B098AMS3733A0
• Version / Model: AMS3733A
• Catalog Number: AMS3733A
• Company Name: Aligned Medical Solutions
• Labeler DUNS: 106580145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-01
• Public Version: 1
• Public Version Date: 2018-12-03
• Public Version Status: New
• Public Device Record Key: d5515ba1-ffde-411f-b07a-78ed44ce4281

Device Description

Nerve Block Tray-RX

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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: Yes
• 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
OGJ	Nerve block tray	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59013	Peripheral nerve-block blunt needle/cannula kit	A collection of sterile devices intended to provide percutaneous access to a peripheral nerve group for injection of an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It typically consists of a plastic nerve-block blunt needle access cannula and a metal nerve-block blunt needle. The cannula is intended to gain percutaneous access, which may be guided by fluoroscopy, to provide a conduit for insertion of the needle for administration of the pharmaceutical. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B098AMS3733A1	HIBCC	case	15	In Commercial Distribution
Primary	B098AMS3733A0	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius