FDA.reportPublic FDA data

Bebeonkers I

Primary DI
00815090011740
Brand
Bebeonkers I
Company
SMALL BEGINNINGS INC
Model
16-1KK
Catalog number
16-1KK
Device description
The Bebeonkers I Oral/Nasal Suction Device with Bebe Keeper Kover is intended to be attached to wall suction and used as an oral or nasal cavity evacuator to remove secretions and maintain a clear airway. In between uses the Bebe Keeper Kover can be placed over suction tip to keep clean. Each unit contains one suction tip and one cover.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815090011747PackageGS150In Commercial Distribution
20815090011744PackageGS14In Commercial Distribution
00815090011740PrimaryGS10
00815090012082Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081509001174710815090011747
2081509001174420815090011744
00815090011740008150900117408150900117400815090011740
00815090012082008150900120828150900120820815090012082

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
760-949-7707kelly@small-beginnings.com

Regulatory Flags#

DUNS number
002657679
Device count
3
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815090013409AP Onkers16-716-72022-12-15
00815090012426Tender and Tiny Tourniquets11TA11TA2020-08-03
00815090012464Tender and Tiny Tourniquets11TH11TH2020-08-03
00815090010026Pacee Pacifier15A15A2020-09-24
10815090010023Pacee Pacifier15A15A2020-09-24
00815090010002Bili-Bonnet01A01A2020-08-03
00815090010019Bili-Bonnet01B01B2020-08-03
00815090010170Bili-Bonnet01C01C2020-08-03
10815090010009Bili-Bonnet01A01A2020-08-03
10815090010016Bili-Bonnet01B01B2020-08-03
10815090010177Bili-Bonnet01C01C2020-08-03
00815090012785Tender and Tiny Tourniquets11TA11TA2020-08-03
10815090012461Tender and Tiny Tourniquets11TH11TH2020-08-03
00815090011436Webeonkers16-016-02020-06-23
10815090011433Webeonkers16-016-02020-06-23
00815090010040Bebeonkers II16-216-22016-09-24
00815090010057Bebeonkers I16-116-12016-09-24
00815090010064Bebe Keeper Kover16-316-32016-09-24
00815090011382Bebeonkers II16-2KK16-2KK2016-09-24
00815090011535Webeonkers16-0KK16-0KK2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253043365CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043372CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
00848530084011Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-06-18
00848530099640Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCX2025-05-21
00848530103996Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-14
00848530104009Oxygen Wrench and Washer KitSunset Healthcare Solutions, Inc.GCX2025-05-14
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08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
00848530105747Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105754Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105723Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105730Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08
08682952417437DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417451DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417482DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
10192253041736ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041743ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041750ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253038965ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038972ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038989ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038996ArgyleCardinal Health 200, LLCGCX2025-02-28