FDA.reportPublic FDA data

Spectra

Primary DI
28809108012849
Brand
Spectra
Company
Uzinmedicare
Model
Spectra accessory(32mm Breast shield)
Device description
This is a funnel shaped accessory, which come in contact with breat to express milk.
Published
2019-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28809108012849PackageGS1200In Commercial Distribution
08809108012937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880910801284928809108012849
08809108012937088091080129378809108012937

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, reusableA collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter32Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+821053081195shahn@uzinmedical.co.kr

Regulatory Flags#

DUNS number
688451947
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18809108011364SpectraSpectra Synergy2020-04-30
28809108011583SpectraSpectra accessory (Accessory Kit_Manual switch)2019-10-19
28809108012825SpectraSpectra accessory(24mm Breast shield) 2019-04-05
28809108012832SpectraSpectra accessory (28mm Breast shield)2019-04-05
28809108011316SpectraSpectra S3 Pro2019-03-22
28809108012467SpectraSpectra accessory (Accessory Kit for S1&S2 ( 20mm 2019-03-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)Ardo medical AGHGX2026-07-30
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