Atellica Ancillary ReadyPack Seals

Basic Information

• Brand Name: Atellica Ancillary ReadyPack Seals
• Primary DI: 00630414306032
• Version / Model: 11208742
• Catalog Number: 11208742
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-07
• Public Version: 2
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 974fa2aa-e2b4-467c-9a8c-c9bbdbe40f85

Device Description

Atellica IM Ancillary Seal Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63765	Assay container liner IVD	A device intended to be used to create a barrier between the assay container and devices used for aspirating and/or depositing (e.g., pipette), to prevent reagent carryover and spillage, during in vitro diagnostic procedures. It may be used to perforate a sealed single or multichannel assay container and create a working channel for subsequent liquid handling. It is typically made of synthetic polymer materials (e.g., plastic) as a single component, or a strip of multiple liners. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414306032	GS1

Customer Contacts

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