FDA.report

Sani Vac Evacuation System Cleaner

Primary DI
00732224109503
Brand
Sani Vac Evacuation System Cleaner
Company
CROSSTEX INTERNATIONAL, INC.
Model
JVAC
Device description
Evacuation System Cleaner
Published
2022-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NRDUnit, operative dental, accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50732224109508PrimaryGS10
00732224109503Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222410950850732224109508
00732224109503007322241095037322241095030732224109503

GMDN Terms

TermDefinition
Patient carrying harnessA device used to assist one or more healthcare professionals or attending persons to physically carry an incapacitated/disabled patient from one place to another over a limited distance. The device is typically made strong textile materials (e.g., nylon, plastic, canvas) and consists of an arrangement of belts and straps to form a harness that is fitted to the person to be carried.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place away from direct sunlight.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(585)359-0167regulatoryaffairs@hu-friedy.com

Regulatory Flags

DUNS number
057728685
Device count
4
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
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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