FDA UDI
In Commercial Distribution
🇺🇸 United States
Spectra
DI: 08809108012302
·
Model: Spectra accessory (24mm shield set)
·
UZINMEDICARE CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- Spectra
- Primary DI
- 08809108012302
- Version / Model
- Spectra accessory (24mm shield set)
- Catalog Number
- MM012302
- Company Name
- UZINMEDICARE CO.,LTD
- Labeler DUNS
- 688451947
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-25
- Public Version
- 5
- Public Version Date
- 2024-09-20
- Public Version Status
- Update
- Public Device Record Key
- 5d4fccb3-675f-48eb-b54d-f0b8bfa77e70
Device Description
Spectra accessory set for breast pump including 24mm breast shield set(excluded bottle set). Breast shield is a funnel shaped accessory, which come in contact with breast to express milk. It is connected to backdraft prevention unit(cap), pressure adjustment unit(silicon head) and bottle when used.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HGX | Pump, Breast, Powered | Obstetrics/Gynecology | 884.5160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61734 | Breast pump support kit, reusable | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809108012302 | GS1 | ||||
| Package | 28809108012306 | GS1 | Carton Box | 50 | In Commercial Distribution | |
| Package | 28809108012412 | GS1 | Carton Box | 48 | In Commercial Distribution | |
| Package | 18809108013108 | GS1 | Design box | 3 | In Commercial Distribution | |
| Package | 28809108013105 | GS1 | Carton box | 18 | In Commercial Distribution |
Customer Contacts
- Phone
- +821053081195
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 24 | Millimeter |