AccessGUDID - DEVICE: PEMCO INC (B1521450JR900)

GUDID

Device Identifier (DI) Information

Brand Name: PEMCO INC
Version or Model: 1450JR-90
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1450JR-90
Company Name: PEMCO INC

Primary DI Number: B1521450JR900
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004217071 *Terms of Use

Device Description: Intracardiac Sucker Set with two Tips – Round, Pediatric Handle at 90 Degree Angle. Comes with Pediatric Tips 1450-15 6.4 mm diameter, 1450-16 4.0 mm diameter. Also fits 1450-17 2.0mm diameter & 1450-17L 2.0mm diameter long. 1450-15 Tip is grooved and slotted to allow for better flow and prevent clogging. Suckers have 3/8" barbed end. * Handles and tips may be ordered as separate items.

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:	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?
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
Length: 7 Inch

Device Record Status

Public Device Record Key: 81bd6e65-8865-40ee-a188-4fc7607197bb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016