User-Fillable Reagent Bottle 50mL Capacity (Link)

Basic Information

• Brand Name: User-Fillable Reagent Bottle 50mL Capacity (Link)
• Primary DI: 05700571104873
• Version / Model: SK203
• Company Name: AGILENT TECHNOLOGIES, INC.
• Labeler DUNS: 084963177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-17
• Public Version: 3
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: 29a2922f-046c-42ba-8103-c81dc4d63bb8

Device Description

User-Fillable Reagent Bottle 50mL Capacity (Link)

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: 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
KPA	Slide stainer, automated	Pathology	864.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62225	Assay container IVD, single-use	A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05700571112496	GS1	Box	25	In Commercial Distribution
Primary	05700571104873	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter

Storage Conditions

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