FDA UDI
In Commercial Distribution
🇺🇸 United States
Nurture Compression Pad
DI: 00850004882276
·
Model: CP-XXL-00-BL-R
·
IMALAC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nurture Compression Pad
- Primary DI
- 00850004882276
- Version / Model
- CP-XXL-00-BL-R
- Catalog Number
- CP-XXL-00-BL-R
- Company Name
- IMALAC, INC.
- Labeler DUNS
- 081299239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-31
- Public Version
- 1
- Public Version Date
- 2019-11-08
- Public Version Status
- New
- Public Device Record Key
- 7b881b91-3dee-442f-8c45-6709ae33a183
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
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| PWA | Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | Obstetrics/Gynecology | 884.5150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38478 | Breast pump, electric | A mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850004882276 | GS1 |