AccessGUDID - DEVICE: Hokanson (00817065020719)

GUDID

Device Identifier (DI) Information

Brand Name: Hokanson
Version or Model: UDC1.9
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 03512
Company Name: D.E.HOKANSON, INC.

Primary DI Number: 00817065020719
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 071829634 *Terms of Use

Device Description: 1.9 x 9 cm digit vascular cuff-Luer Connector

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:	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?
34978	Blood pressure cuff, reusable	A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXQ	Blood Pressure Cuff

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041689	000

Device Exempt from Premarket Submission: No 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
Length: 9 Centimeter
Width: 1.9 Centimeter

Device Record Status

Public Device Record Key: 5547e978-89fb-4865-8fd4-d5de6cc5ef01
Public Version Date: October 02, 2020
Public Version Number: 5
DI Record Publish Date: September 09, 2016