FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00817827025013
·
Model: T2286
·
CHARTER MEDICAL, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00817827025013
- Version / Model
- T2286
- Catalog Number
- T2286
- Company Name
- CHARTER MEDICAL, LTD.
- Labeler DUNS
- 029062325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3ef854cd-d502-4181-bdc5-b3c3cd008c27
Device Description
150mL Six Bag Aliquot System With Peircinh Pin and Needless Syringe Adapter
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Hematology | 864.9100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46346 | Paediatric blood donor set | A sterile assembly consisting of multiple collection containers (typically five connected flexible bags) of smaller volume than those used in adult sets. It is used for the storage of adult donor blood which is decanted from a normal adult size pack into this device in order to create smaller paediatric volume packs for infusion. The individual paediatric packs are then separated and sealed for later infusion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817827025518 | GS1 | 24 | In Commercial Distribution | ||
| Primary | 00817827025013 | GS1 |
Customer Contacts
- Phone
- (866) 458-3116
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK960043 | 0 |