Simmler, Inc.

GUDID 00851318008000

Fetal Cell Stain Kit 300 Test

SIMMLER INC

Haemoglobin F (HbF) IVD, reagent

• Primary Device ID: 00851318008000
• NIH Device Record Key: fd7cdcb2-f262-48e9-9cf8-506bb56a3f44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simmler, Inc.
• Version Model Number: S0412-00
• Company DUNS: 056955776
• Company Name: SIMMLER INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6363768347
• Email: customerservice@simmler.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851318008000 [Primary]

FDA Product Code

• GHQ: Stain, Fetal Hemoglobin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-19

On-Brand Devices [Simmler, Inc.]

• 00851318008048: Fetal Cell Fixing Solution
• 00851318008031: Fetal Cell Citrate Buffer
• 00851318008024: Fetal Cell Staining Solution
• 00851318008017: Fetal Cell Stain Kit 100 Test
• 00851318008000: Fetal Cell Stain Kit 300 Test