DISPETTE®

Basic Information

• Brand Name: DISPETTE®
• Primary DI: 07612964000762
• Version / Model: FH1650
• Catalog Number: FH1650
• Company Name: Guest Scientific AG
• Labeler DUNS: 483342734
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-11-07
• Public Version: 2
• Public Version Date: 2021-10-20
• Public Version Status: Update
• Public Device Record Key: c038d0ba-a0da-4939-8c6a-e75f32d47d22
• Distribution End Date: 2021-06-30

Device Description

DISPETTE 2 CITRATE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
JPH	Test, Erythrocyte Sedimentation Rate	Hematology	864.6700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55970	Erythrocyte sedimentation rate (ESR) IVD, kit	A collection of reagents and other associated materials intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07612964000809	GS1	CASE	10	Not in Commercial Distribution	2021-06-30
Primary	07612964000762	GS1
Unit of Use	07612964000786	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 24 Degrees Celsius