Sample Preparation System (Stool)

Basic Information

• Brand Name: Sample Preparation System (Stool)
• Primary DI: 00404847456745
• Version / Model: EIA-5674
• Catalog Number: EIA-5674
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• Labeler DUNS: 317134468
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 1
• Public Version Date: 2021-06-15
• Public Version Status: New
• Public Device Record Key: f4cf12c9-7e52-4c04-88ca-768bc22ea07c

Device Description

A collection of devices intended to be used for the collection, preservation, and transport of any type of clinical specimen from any body part.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
NNK	CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65306	General specimen collection kit IVD, no additive	A collection of devices intended to be used for the collection, preservation, and transport of any type of clinical specimen (e.g., faeces, sputum, mucous, wound exudate, vaginal secretion) collected from any body part [e.g., natural orifice, skin (i.e., it is not dedicated to a body region)] for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture, histopathology, microscopy]. It includes a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a closable plastic receptacle with no additive. This a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00404847456745	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius