FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDURE INDUSTRIES
DI: 00840118614641
·
Model: IDPBA8
·
ENDURE INDUSTRIES
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ENDURE INDUSTRIES
- Primary DI
- 00840118614641
- Version / Model
- IDPBA8
- Catalog Number
- IDPBA8
- Company Name
- ENDURE INDUSTRIES
- Labeler DUNS
- 066087031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-10
- Public Version
- 1
- Public Version Date
- 2024-04-18
- Public Version Status
- New
- Public Device Record Key
- be56299e-cbe9-4a94-bbca-45f0458dcf6a
Device Description
Medical ID Bracelets, Pediatric, Blue
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZZ | Marker, Skin | General, Plastic Surgery | 878.4660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32048 | Patient identification band | A single-piece circular band designed to be worn around the wrist (i.e., bracelet, wristband), or sometimes ankle in babies, to provide identification and basic information about a patient. It is typically a slender, thin, and soft plastic band, with a self-locking device, that usually includes printed information with the name, date of birth, patient registration number, and other data that permit clear and easy identification of a patient in the healthcare facility. Some devices also include bar-code information intended for reading with a computerized reader/scanner. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840118614658 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00840118614641 | GS1 | ||||
| Package | 00840118614665 | GS1 | Case | 2000 | In Commercial Distribution |
Customer Contacts
- Phone
- 6072994971
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 49 Degrees Celsius