FDA UDI
In Commercial Distribution
🇺🇸 United States
35 mL Breast Milk Collection & Storage Container
DI: 20020451289728
·
Model: 87110S-50
·
MEDELA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- 35 mL Breast Milk Collection & Storage Container
- Primary DI
- 20020451289728
- Version / Model
- 87110S-50
- Company Name
- MEDELA, INC.
- Labeler DUNS
- 052002029
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-03-06
- Public Version
- 1
- Public Version Date
- 2023-03-14
- Public Version Status
- New
- Public Device Record Key
- 012c9222-9e8f-460e-ae63-2ef70ebfb8bb
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| 61715 | Infant feeding bottle, single-use | An empty glass or plastic container typically with a relatively narrow neck and removable nipple, intended to feed (nurse) infants, typically with milk, but sometimes with other fluids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20020451289728 | GS1 | ||||
| Unit of Use | 00020451871103 | GS1 |