FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BacT/ALERT® Blood Collection Adapter Insert
DI: 03573026556129
·
Model: BacT/ALERT® Blood Collection Adapter Insert
·
BIOMERIEUX , INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
60
Basic Information
- Brand Name
- BacT/ALERT® Blood Collection Adapter Insert
- Primary DI
- 03573026556129
- Version / Model
- BacT/ALERT® Blood Collection Adapter Insert
- Company Name
- BIOMERIEUX , INC.
- Labeler DUNS
- 086785110
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2016-12-14
- Public Version
- 5
- Public Version Date
- 2021-03-23
- Public Version Status
- Update
- Public Device Record Key
- a44a7cae-5160-41ca-8b4e-25663091ba72
- Distribution End Date
- 2021-02-26
Device Description
The Adapter Insert is used with The BacT/ALERT Blood Collection Adapter. It can be locked inside the Adapter Cap to allow blood to be filled into vacuum collection tubes.
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 |
|---|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36188 | Blood collection tube holder, reusable | A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03573026125769 | GS1 | 1 | Not in Commercial Distribution | 2021-02-26 | |
| Primary | 03573026556129 | GS1 | ||||
| Unit of Use | 03573026556112 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K933939 | 000 |