FDA.reportPublic FDA data

Bebeonkers II

Primary DI
00815090011382
Brand
Bebeonkers II
Company
SMALL BEGINNINGS INC
Model
16-2KK
Catalog number
16-2KK
Device description
The Bebeonkers II Oral/Nasal Suction Device for the Ultra Preemie infant 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
10815090011389PackageGS150In Commercial Distribution
20815090011386PackageGS14In Commercial Distribution
00815090011382PrimaryGS10
00815090012099Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081509001138910815090011389
2081509001138620815090011386
00815090011382008150900113828150900113820815090011382
00815090012099008150900120998150900120990815090012099

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
00815090011535Webeonkers16-0KK16-0KK2016-09-24
00815090011740Bebeonkers I16-1KK16-1KK2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956534681CARDINAL HEALTHCardinal Health 200, LLCGCX2026-07-27
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
00848530105464Washer with Rubber Ring - AluminumSunset Healthcare Solutions, Inc.GCX2025-05-14
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