FDA.reportPublic FDA data

Hyper-Sal

Primary DI
00744229235125
Brand
Hyper-Sal
Company
PARI RESPIRATORY EQUIPMENT, INC.
Model
300F3502
Device description
Hyper-Sal 3.5% Hypertonic Saline w/ LC Plus
Published
2016-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070498000HYPER SALPari Innovative Manufacturers, Inc.2007-04-26CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00744229235125PackageGS112In Commercial Distribution
00744229235606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00744229235125007442292351257442292351250744229235125
00744229235606007442292356067442292356060744229235606

GMDN Terms#

Term, Definition table
TermDefinition
Inhalation therapy saline solution, hypertonicA sterile, hypertonic saline solution, consisting only of water and sodium chloride (> 0.9% NaCl) intended to be used for the induction of sputum in a patient, via physiological osmotic mechanisms, especially indicated for palliative treatment of cystic fibrosis (CF). It is intended to be used with a nebulizer to produce a mist that can be inhaled into the lungs where cells lining the airways are triggered to release water and facilitate restoration of the layer of moisture lining the airways for clearing of mucous. The solution is typically available in a single unit-of-use container. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
804736098
Device count
1
DM exempt
false
Premarket exempt
false
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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Primary DI, Brand, Model table
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00744229440857Vortex044F81002024-04-30
00744229440864Vortex044F82002024-04-30
00744229100850Vortex044F81002024-04-30
00744229100867Vortex044F82002024-04-30
00744229510475Vortex051F80002024-04-26
00744229510529Vortex051F80002024-04-26
00744229510482Vortex051F81002024-04-23
00744229510499Vortex051F82002024-04-23
00744229510505Vortex051H84002024-04-23
00744229510581Vortex051F83002024-04-23
00744229510536Vortex051F81002024-04-23
00744229510543Vortex051F82002024-04-23
00744229510512Vortex051H84002024-04-23
00744229510598Vortex051F83002024-04-23
00744229230205LC Sprint Star023F41na2023-08-10
00744229440703Wing Tip044E00552023-06-28
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00744229100706Proneb Max130F35-LCSna2020-05-22
00744229440840Bubbles044F72542023-04-13

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