FDA UDI
In Commercial Distribution
🇺🇸 United States
Symphony Breastmilk Initiation Kit-Sterile
DI: 00020451673509
·
Model: 67350S
·
MEDELA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Symphony Breastmilk Initiation Kit-Sterile
- Primary DI
- 00020451673509
- Version / Model
- 67350S
- Company Name
- MEDELA, INC.
- Labeler DUNS
- 052002029
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-12
- Public Version
- 3
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 2e829c97-9f99-47c8-b163-4ab1099c47e1
Device Description
Breast pump kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHH | Breast Pump Kit | Obstetrics/Gynecology | 884.5160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12463 | Breast pump support kit, single-use | 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 milk collection containers (e.g., bottle, cup). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10020451673506 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 00020451673509 | GS1 |
Customer Contacts
- Phone
- 8004358316
- [email protected]