AccessGUDID - DEVICE: Neonate Cuff (00847946026820)

GUDID

Device Identifier (DI) Information

Brand Name: Neonate Cuff
Version or Model: 1009-001644
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Medical Corporation

Primary DI Number: 00847946026820
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055363428 *Terms of Use

Device Description: ASSY, CUFF, NEONATE #5, LIMB CIRCUMFERENCE 8.0 CM TO 15.0 CM, DISPOSABLE (BOX OF 20)

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:	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?
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 [?]
K120125	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
Storage Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Handling Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 88090a07-b22e-41a6-8434-2a45b19d50ab
Public Version Date: November 17, 2023
Public Version Number: 1
DI Record Publish Date: November 09, 2023