FDA.reportPublic FDA data

BoogieBaby nasal aspirator – olive tip 4.5 inch long

Primary DI
10814247021080
Brand
BoogieBaby nasal aspirator – olive tip 4.5 inch long
Company
CLINICAL INNOVATIONS, LLC
Model
VPBB150112100
Device description
BoogieBaby nasal aspirator – olive tip 4.5 inch long
Published
2021-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BYYTube, Aspirating, Flexible, Connecting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814247021080PackageGS1100In Commercial Distribution
20814247021087PackageGS18In Commercial Distribution
00814247021083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081424702108010814247021080
2081424702108720814247021087
00814247021083008142470210838142470210830814247021083

GMDN Terms#

Term, Definition table
TermDefinition
Nasal aspirator, electricA portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It consists of a handgrip that contains the batteries, a small electric pump that creates the suction, and typically has a silicone nozzle attached to a detachable, washable, collection cup at the distal end. It is designed for domestic use and is typically applied superficially the nasal opening (i.e., not inserted into the nasal cavity). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809524291
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00814247021328Panniculus Retraction Kit: traxi and ABBy - LargePRS-CK-05LG2026-05-31
00814247020345traxi® Panniculus RetractorPRS-10302016-09-01
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30814247020360traxi® Panniculus Retractor ExtenderPRS-05502016-09-01
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00814247021243Kiwi® OmniCup®VAC-DUAL MT2025-12-16
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00814247020536FSE CablesSBT-70122016-09-01
00814247020543FSE CablesSBT-70142016-09-01
00814247020550FSE CablesSBT-70152016-09-01
00814247020567FSE CablesSBT-70162016-09-01
00814247020574FSE CablesSBT-70172016-09-01
00814247020581FSE CablesSBT-70182016-09-01

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