FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NOVO Health Services, LLC
DI: 00810019800016
·
Model: 123627
·
NOVO HEALTH SERVICES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NOVO Health Services, LLC
- Primary DI
- 00810019800016
- Version / Model
- 123627
- Catalog Number
- 123627A
- Company Name
- NOVO HEALTH SERVICES, LLC
- Labeler DUNS
- 069936106
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-15
- Public Version
- 4
- Public Version Date
- 2023-10-27
- Public Version Status
- Update
- Public Device Record Key
- b79704da-4832-4270-ad02-302bf8848925
- Distribution End Date
- 2023-10-23
Device Description
Blanket, Baby
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNC | Table, Obstetric (And Accessories) | Obstetrics/Gynecology | 884.4900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58934 | Infant blanket, single-use | A piece of fabric material intended to be used to wrap newborns/infants to retain their body heat and/or absorb fluids. Commonly known as a baby blanket, it is available in a variety of fabrics (e.g., wool, cotton, or synthetic materials) and textures (e.g., cellular or smooth). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810019800016 | GS1 |
Customer Contacts
- Phone
- 8138919550
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 6 | Inch | |
| Width | 8 | Inch | |
| Weight | 0.3 | Pound |