AccessGUDID - DEVICE: Unimed (06945664867856)

GUDID

Device Identifier (DI) Information

Brand Name: Unimed
Version or Model: N1681S-C05-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Unimed Medical Supplies, Inc.

Primary DI Number: 06945664867856
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 527971025 *Terms of Use

Device Description: Disposable NIBP cuff/TPU/Single Tube/Neonate#1/wigh BP05-P connector/No Unimed Logo

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Blood pressure cuff, single-use	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 typically wrapped around the upper arm of the patient. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Blood pressure cuff, single-use

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 typically wrapped around the upper arm of the patient. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
DXQ	Blood Pressure Cuff

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120364	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
No Device Sizes

Device Record Status

Public Device Record Key: ac605711-5a25-48a3-b34c-3896c4b7a528
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 24, 2016