AccessGUDID - DEVICE: ELMED (00842180175983)

GUDID

Device Identifier (DI) Information

Brand Name: ELMED
Version or Model: SM24-101BC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SM24-101BC
Company Name: ELMED INCORPORATED

Primary DI Number: 00842180175983
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049290364 *Terms of Use

Device Description: REMOVABLE CARDIAC SUMP TIP WITH ATTACHMENT TO SUCTION TUBE PER CUSTOMERS SPECIFICATIONS. POOLE TYPE TIP 6.3MM DIA., X 30MM LONG WITH ROW OF 7 HOLES X 8 SIDES PLUS AT TIP, SUCTIONTUBE 3.8MM DIA., TIP WITH 6 HOLES AT DISTAL END 18MM LONG ATTACHED TO 6MM DIA., TUBE 130MM LONG WITH BARB, HOSE FITTING END SURGICAL STAINLESS STEEL

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):	Yes
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?
64119	Surgical irrigation/aspiration cannula, non-illuminating, reusable	An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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
No Device Sizes

Device Record Status

Public Device Record Key: 38178272-730f-4011-a5ba-3ddb08b2ca2a
Public Version Date: August 29, 2023
Public Version Number: 1
DI Record Publish Date: August 21, 2023