AccessGUDID - DEVICE: MEDRAD® Veris™ 8600 Vital Signs Monitor (00616258009520)

GUDID

Device Identifier (DI) Information

Brand Name: MEDRAD® Veris™ 8600 Vital Signs Monitor
Version or Model: 3011544
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3011544
Company Name: BAYER MEDICAL CARE INC.

Primary DI Number: 00616258009520
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058716649 *Terms of Use

Device Description: "Adult Blood Pressure Disposable Cuffs 14.5-19 in (37-48.5 cm) (BP CUFF, DISP, 37-49CM, VERIS,MC) (85278142)"

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:	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?
37326	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042569	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: 3a47c377-6355-4667-9dd8-57383a0e959f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 23, 2017