FDA UDI
In Commercial Distribution
🇺🇸 United States
A Plus
DI: 00683534810019
·
Model: 1
·
A PLUS INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- A Plus
- Primary DI
- 00683534810019
- Version / Model
- 1
- Catalog Number
- BB-3038-1S
- Company Name
- A PLUS INTERNATIONAL INC.
- Labeler DUNS
- 191705904
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-18
- Public Version
- 2
- Public Version Date
- 2022-10-27
- Public Version Status
- Update
- Public Device Record Key
- d76a098a-6d75-4a93-ad97-0c097b5d7b00
Device Description
Baby Blanket , Style: Stripes, Steam Pretreatment, 12Pc(s)/Polybag, 72Pc(s)/Case
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization", "Radiation Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KME | Bedding, Disposable, Medical | General Hospital | 880.6060 | 1 |
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 |
|---|---|---|---|---|---|---|
| Package | 80683534810015 | GS1 | Case | 72 | In Commercial Distribution | |
| Primary | 00683534810019 | GS1 |