Specimen Cup

Basic Information

• Brand Name: Specimen Cup
• Primary DI: 07612367015271
• Version / Model: 077.0094
• Company Name: Medela AG
• Labeler DUNS: 488293218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-12-05
• Public Version: 11
• Public Version Date: 2025-11-10
• Public Version Status: Update
• Public Device Record Key: 5b55492f-0180-45cf-98b6-860b4d08dbfb

Device Description

Specimen Cup for reusable collection system

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	878.4780	2
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	878.5040	2
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	878.5040	2
HDB	Extractor, Vacuum, Fetal	Obstetrics/Gynecology	884.4340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07612367015271	GS1
Unit of Use	07612367051385	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130123	000
K150134	000
K153663	000
K170329	000