FDA.reportPublic FDA data

SALINE LOCK KIT

Primary DI
M68980110140
Brand
SALINE LOCK KIT
Company
Safeguard US Operating, LLC
Model
14
Catalog number
80-110
Device description
The Mojo® Saline Lock Kit allows for quick and effective extremity venous cannulation under the most demanding conditions in one complete set. It contains the necessary items for starting and securing a saline lock. The rugged, low-cube, vacuum-sealed pouch keeps the contents of the kit in prime condition until needed.
Published
2025-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRSI.V. Start Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68980110140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wound irrigation cannulaA rigid or semi-rigid tube intended to be connected to a parent device (e.g., syringe) to channel irrigation fluids (e.g., saline solution) to a skin or surgical wound for washing and removing debris; it is not intended for aspiration of fluids. This is a single-use device intended to be used in a sterile condition.

Contacts#

Phone, Email table
PhoneEmail
1-855-428-6074sales@safeguardmedical.com

Regulatory Flags#

DUNS number
118492643
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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M689HHSCK01EA020Simplified Cricothyrotomy Kit02HHSCK01-EA2022-08-10
M68985201020Mojo Vehicle Rescue Bag - Basic0285-2012026-01-30
M6898723101030Bleeding Control Kit0387-231-012026-07-30
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M6898810501060Patrol Officer IFAK Basic0688-105-012026-07-27
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