FDA UDI
In Commercial Distribution
🇺🇸 United States
GD
DI: 00850699008197
·
Model: BB3040
·
Jiangsu Guangda Medical Material Group Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- GD
- Primary DI
- 00850699008197
- Version / Model
- BB3040
- Catalog Number
- BB3040
- Company Name
- Jiangsu Guangda Medical Material Group Co.,Ltd.
- Labeler DUNS
- 421295761
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 2
- Public Version Date
- 2024-06-19
- Public Version Status
- Update
- Public Device Record Key
- d1871c93-511c-4be3-a4f8-5bd8fb162aa5
Device Description
Baby Blanket 30 x 40
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 60823 | Bed linen set | A collection of bedding materials including a bed sheet, pillow cover, and a duvet cover all typically made of a thin non-woven or textile laminate intended to create a physical barrier to soiling and cross-contamination. It does not include antimicrobial properties. This set is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850699008845 | GS1 | ||||
| Primary | 00850699008197 | GS1 |
Customer Contacts
- Phone
- 630.842.6595
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 100 Degrees Fahrenheit