AccessGUDID - DEVICE: N/A (00647011911415)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: ZNC4702L-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ZNC4702L-1..
Company Name: SALTER LABS

Primary DI Number: 00647011911415
Issuing Agency: GS1
Commercial Distribution End Date: July 24, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 022721133 *Terms of Use

Device Description: NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Double Tube 7-24-2020 original Primary DI above was entered in error. The correct DI is 00607411911415.

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):	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
DXQ	blood pressure cuff

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K921997	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
Device Size Text, specify: Neonatal

Device Record Status

Public Device Record Key: 0052af6f-cd54-44e6-ba63-ee2fec760ae3
Public Version Date: July 27, 2020
Public Version Number: 4
DI Record Publish Date: February 24, 2017