AccessGUDID - DEVICE: DELTRAN (H671ABC248A60)

GUDID

Device Identifier (DI) Information

Brand Name: DELTRAN
Version or Model: PLUS ABC KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ABC-248A-6
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H671ABC248A60
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094651270 *Terms of Use

Device Description: Disposable Pressure Transducer System, 3cc/hr Flow Rate with Arterial Blood Collection System, 48/12", Macro Drip Chamber, 6cc Reservoir

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?
45760	In-line arterial blood sampling set	A collection of sterile devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. It is a haemodynamic pressure monitoring and blood gas sampling device, typically designed for use with disposable/reusable pressure transducers, intended to connect to a central line/arterial catheter from which the blood specimen is obtained. Heparinized blood may be reinfused into the patient via the device to reduce fluid loss. This is a single-patient device that may be used short term (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBT	Arterial Blood Sampling Kit

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: Yes
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: Flow Rate - 3 cc/hr

Device Record Status

Public Device Record Key: 3293bf1a-5e68-4bad-b225-980202ecfdf3
Public Version Date: December 18, 2019
Public Version Number: 3
DI Record Publish Date: September 23, 2016