AccessGUDID - DEVICE: LTV (10190752129788)

GUDID

Device Identifier (DI) Information

Brand Name: LTV
Version or Model: 11475
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11475
Company Name: VYAIRE MEDICAL, INC.

Primary DI Number: 10190752129788
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080456871 *Terms of Use

Device Description: Small External 12V Replacement Battery

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?
36545	Basic power supply, reusable	A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBK	Ventilator, continuous, facility use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101643	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: c0f046ed-2f67-49a6-82f7-895f48ad3024
Public Version Date: July 22, 2021
Public Version Number: 2
DI Record Publish Date: March 19, 2021

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: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(833)327-3284
Email: customersupport@vyaire.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES