903 DBS Collection Cards - 5 Samples

Basic Information

• Brand Name: 903 DBS Collection Cards - 5 Samples
• Primary DI: 00816870021300
• Version / Model: 621MM
• Catalog Number: 621MM
• Company Name: MONOBIND, INC.
• Labeler DUNS: 083155515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-13
• Public Version: 1
• Public Version Date: 2024-09-23
• Public Version Status: New
• Public Device Record Key: 3fdbbe29-049d-40ab-bc42-0c07bd9a7264

Device Characteristics

• Single Use: Yes
• 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: 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
PJC	Newborn screening specimen collection paper	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66256	Dried blood spot collection card IVD	A device intended to be used for dried blood spot collection and preservation, at the point-of-care, for subsequent diagnostic testing or screening. It is typically in the form of paper integrated in a card, on which a whole blood specimen is applied and absorbed onto the collection paper. The card may include a form to capture patient demographic information This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816870021300	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	3	Inch