AccessGUDID - DEVICE: PEMCO INC (B15214600)

GUDID

Device Identifier (DI) Information

Brand Name: PEMCO INC
Version or Model: 1460
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1460
Company Name: PEMCO INC

Primary DI Number: B15214600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004217071 *Terms of Use

Device Description: Intracardiac Sucker: Flat, Pediatric Handle Fixed Tip, 3.2 mm diameter. Handle is 7.5 inches long with a 30 Degree Angle. Tips are grooved and slotted to allow for better flow and prevent clogging. Suckers have 5/16" barbed end. Alternate tip and handle styles are available.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
Over the Counter (OTC):	No
Kit:	No
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?
45254	Suction cannula, reusable	A rigid or semi-rigid, hand-held, metal or durable plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open-, plastic-, tissue/bone morcellation surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Angle: 30 degree
Length: 7.5 Inch
Outer Diameter: 3.2 Millimeter

Device Record Status

Public Device Record Key: b4b3a945-d7eb-4bcd-b99a-5965de886aaf
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016