J&J DePuy Synthes convenience kit

Basic Information

• Brand Name: J&J DePuy Synthes convenience kit
• Primary DI: 07612367080590
• Version / Model: 101043438
• Catalog Number: 101043438
• Company Name: Medela AG
• Labeler DUNS: 488293218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-01
• Public Version: 1
• Public Version Date: 2021-12-09
• Public Version Status: New
• Public Device Record Key: ffaee3b1-037e-45c4-8d64-6d0d40e280e2

Device Description

Convenience kit containing: 1 x Dominant Flex Rack (item # 071.0003 ) with U.S. power cord 1 pack of Coupling Piece 90° (item # 077.1019, 10 pieces) 1 x IFU of each language region (EU 1, EU 2, Japan, Korea, China)

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• 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
HDB	Extractor, Vacuum, Fetal	Obstetrics/Gynecology	884.4340	2
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	878.5040	2
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	878.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63642	Surgical suction pump	An electrically-powered device, which may include noninvasive accessories, intended to generate negative pressure for aspiration of body cavities/wounds during a variety of surgical procedures (e.g., general surgery, liposuction, and laparoscopy), typically to facilitate observation; it may also be intended for airway/oral cavity clearance. It is not intended for vascular/thrombectomy use and is not dedicated to thoracic drainage or dental applications; it is not designed for surgical irrigation. The device may incorporate a pressure gauge/controls, and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07612367080590	GS1

Customer Contacts

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