FDA.reportPublic FDA data

NebuSal 3% USP

Primary DI
40850877007002
Brand
NebuSal 3% USP
Company
PHARMACARIBE, LLC.
Model
14263
Catalog number
50190-142-63
Device description
Carton with 60 vials: 3% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K101424000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101424000PHARMACARIBE INHALED SALINE SOLUTIONSPharmacaribe2010-08-17CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60850877007006PackageGS112In Commercial Distribution
40850877007002PrimaryGS10
00850877007004Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6085087700700660850877007006
4085087700700240850877007002
00850877007004008508770070048508770070040850877007004

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
804-339-4523werner.gutmann@pharmacaribe.com

Regulatory Flags#

DUNS number
011702541
Device count
60
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
40850877007019NebuSal 6% USP5232350190-523-232016-10-07
40850877007033PulmoSal 7% (pH+)7406050190-740-602016-10-07
60850877007006NebuSal 3% USP1426350190-142-632016-10-07
60850877007013NebuSal 6% USP5232350190-523-232016-10-07
40850877007026Sodium Chloride Solution USP 7%1412350190-141-232016-10-07
60850877007037PulmoSal 7% (pH+)7406050190-740-602016-10-07

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Primary DI, Brand, Company table
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