FDA.reportPublic FDA data

Pacee Pacifier

Primary DI
00815090010026
Brand
Pacee Pacifier
Company
SMALL BEGINNINGS INC
Model
15A
Catalog number
15A
Device description
Lil' Pacee preemie pacifier intended to soothe infants in the NICU especially for use with respiratory products.
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEFRing, Teething, Non-Fluid Filled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEFRing, Teething, Non-Fluid FilledDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815090010023PackageGS1100In Commercial Distribution
20815090010020PackageGS14In Commercial Distribution
00815090010026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081509001002310815090010023
2081509001002020815090010020
00815090010026008150900100268150900100260815090010026

GMDN Terms#

Term, Definition table
TermDefinition
Infant oral pacifierA device, designed as an artificial teat, intended to be placed in the mouths of irritable or teething infants to quiet/pacify them. This is a reusable device.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
002657679
Device count
1
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
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
00815090011740Bebeonkers I16-1KK16-1KK2016-09-24

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Primary DI, Brand, Company table
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00850036595274Chewy TubesCASCO BAY MOLDING LTD.MEF2025-01-24
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