AccessGUDID - DEVICE: J&J DePuy Synthes convenience kit (07612367080590)

GUDID

Device Identifier (DI) Information

Brand Name: J&J DePuy Synthes convenience kit
Version or Model: 101043438
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101043438
Company Name: Medela AG

Primary DI Number: 07612367080590
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 488293218 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTA	Pump, Portable, Aspiration (Manual Or Powered)
HDB	Extractor, Vacuum, Fetal
MUU	System, Suction, Lipoplasty
QPB	System, Suction, Lipoplasty For Removal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ffaee3b1-037e-45c4-8d64-6d0d40e280e2
Public Version Date: December 09, 2021
Public Version Number: 1
DI Record Publish Date: December 01, 2021