SeromaCath

Basic Information

• Brand Name: SeromaCath
• Primary DI: 00854373007001
• Version / Model: 1002 Pouch
• Catalog Number: 1002
• Company Name: GREER MEDICAL, INC.
• Labeler DUNS: 800169260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-10
• Public Version: 4
• Public Version Date: 2022-03-08
• Public Version Status: Update
• Public Device Record Key: f124d4c3-d514-4d02-8202-207bbae1bc23

Device Description

Original SeromaCath Wound Drainage System 14G (2,1mm) x 2" (5cm)

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	878.4680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11305	Closed-wound drain, non-bioabsorbable	A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854373007001	GS1
Package	00854373007018	GS1	Box	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905733	000

Device Sizes

Type	Value	Unit	Text
Length	2	Inch
Device Size Text, specify			Catheter Gauge: 14: Gauge

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 33 – 105 Degrees Fahrenheit