Atellica IM Calibrator A

Basic Information

• Brand Name: Atellica IM Calibrator A
• Primary DI: 00630414598284
• Version / Model: 10995501
• Catalog Number: 10995501
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 2
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 3f46f494-dd47-4ca7-aa7f-3e0a47809b32

Device Description

Calibrator A - Atellica IM CAL (6PK) 2 x 6 x 5.0 mL

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: No
• 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
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30504	Multiple human hormone IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of multiple human hormones in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414598284	GS1
Unit of Use	00630414190754	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K961510	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store upright