AccessGUDID - DEVICE: LifeVac School KIT (B712LVC3003)

GUDID

Device Identifier (DI) Information

Brand Name: LifeVac School KIT
Version or Model: LVC3003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LIFEVAC, INC.

Primary DI Number: B712LVC3003
Issuing Agency: HIBCC
Commercial Distribution End Date: March 04, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 071298464 *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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
63287	Emergency airway clearance suction plunger	A noninvasive, manual device designed for the emergency removal of an airway-obstructing object or material in the oropharynx, trachea, or bronchi to prevent patient asphyxiation. It is in the form of a compression tank (plunger) connected to a face-fitting mask that is applied to the mouth area; the plunger is manually compressed and expanded to provide a negative pressure within the airway to suck out the obstructing material. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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: a5a5a2a3-d9b9-41b4-be58-925ff8d9e9d0
Public Version Date: May 06, 2026
Public Version Number: 3
DI Record Publish Date: September 25, 2020

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

Customer Contact

[?]

Phone: +1-516-965-1900
Email: soliveri@lifevac.net

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