AccessGUDID - DEVICE: 32nd Street Media (00860011846406)

GUDID

Device Identifier (DI) Information

Brand Name: 32nd Street Media
Version or Model: TMB-2084-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nicole Anderson Media Services, LLC

Primary DI Number: 00860011846406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078733061 *Terms of Use

Device Description: No description.

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?
62279	Blood pressure cuff inflation regulator	A mains-electricity (AC-powered) device intended to interface between an air compressor and a vascular cuff to regulate rapid inflation of the cuff during procedures to assess vascular health (e.g., venous insufficiency, maximum venous outflow, arterial inflow). Intended to be used by a healthcare professional in a clinical setting, it consists of a compact unit with display/controls, pressure regulator, and tubing to connect to the cuff. It is intended to regulate inflation to a preselected target pressure, to maintain that pressure, and subsequently deflate the cuff; it may be intended to be used with a timer for automatically-triggered inflation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 91dc19cd-6398-4d38-b6ff-ab478b4d8558
Public Version Date: April 16, 2024
Public Version Number: 1
DI Record Publish Date: April 08, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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