AccessGUDID - DEVICE: Cannulaide (10607411007276)

GUDID

Device Identifier (DI) Information

Brand Name: Cannulaide
Version or Model: HF101-0-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HF101-0-25
Company Name: SALTER LABS

Primary DI Number: 10607411007276
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022721133 *Terms of Use

Device Description: High Flow Cannulaide clear silicone cannula securement device for infants <1250 g

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":	Yes
For Single-Use:	Yes
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?
59024	Universal patient tubing holder, non-sterile	A small, non-sterile device with a locking/holding mechanism designed to secure tubing or tubing-like devices (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. It is not designed to hold a specific type or brand of tubing. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CAT	CANNULA, NASAL, OXYGEN

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Infant

Device Record Status

Public Device Record Key: 8359ddbd-c6e0-4d31-a5fb-8a215af76d1f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016