FDA UDI
In Commercial Distribution
🇺🇸 United States
Transonic
DI: 00877466002141
·
Model: HQD3FMV
·
TRANSONIC SYSTEMS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Transonic
- Primary DI
- 00877466002141
- Version / Model
- HQD3FMV
- Company Name
- TRANSONIC SYSTEMS INC.
- Labeler DUNS
- 101317451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-08
- Public Version
- 2
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- 6cdfc1cb-a76b-491f-bc3d-3ce34f9e79a8
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide, Hydrogen Peroxide, Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | Cardiovascular | 870.2100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61341 | Surgical anti-adhesion material, implantable, non-bioabsorbable | A non-bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) of one internal body part/tissue to another following a surgical procedure. The device is typically implanted during abdominal, pelvic, or spinal surgery to reduce the incidence of adhesions between adjacent anatomical structures. It is typically made of a single or composite polymer (e.g., hydrogel) in the form of a barrier membrane or fluid dressing; neither antimicrobials nor pharmaceuticals are included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00877466002141 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K872048 | 000 |