FDA UDI
In Commercial Distribution
🇺🇸 United States
DonorCare® Needle Guard Large Channel
DI: 19555240400151
·
Model: A100150
·
ITL ASIA PACIFIC SDN. BHD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- DonorCare® Needle Guard Large Channel
- Primary DI
- 19555240400151
- Version / Model
- A100150
- Catalog Number
- A100150
- Company Name
- ITL ASIA PACIFIC SDN. BHD.
- Labeler DUNS
- 597723837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2020-09-20
- Public Version
- 1
- Public Version Date
- 2020-09-28
- Public Version Status
- New
- Public Device Record Key
- 4a855c84-4c36-4e63-a8d7-debee7e9ce8a
Device Description
DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KSS | Supplies, Blood-Bank | Hematology | 864.9050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17812 | Needle guard | A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 09555240400154 | GS1 | ||||
| Primary | 19555240400151 | GS1 |
Customer Contacts
- Phone
- +18884112851
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK980008 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Direct Sunlight