Simmler, Inc.

Basic Information

• Brand Name: Simmler, Inc.
• Primary DI: 00851318008017
• Version / Model: S0412-100
• Company Name: SIMMLER INC
• Labeler DUNS: 056955776
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 75b9c519-3187-4071-a200-bbabd067cf95

Device Description

Fetal Cell Stain Kit 100 Test

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
GHQ	Stain, Fetal Hemoglobin	Hematology	864.7455	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55900	Haemoglobin F (HbF) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of haemoglobin subtype F (HbF), also known as foetal haemoglobin, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851318008017	GS1

Customer Contacts

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