FDA UDI
In Commercial Distribution
🇺🇸 United States
HEMOBLAST Bellows
DI: 03760193182705
·
Model: BQF02
·
DILON TECHNOLOGIES FRANCE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HEMOBLAST Bellows
- Primary DI
- 03760193182705
- Version / Model
- BQF02
- Catalog Number
- BQF02-US
- Company Name
- DILON TECHNOLOGIES FRANCE
- Labeler DUNS
- 279346203
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-19
- Public Version
- 6
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- ad8aa1bb-2cda-4c70-9f51-60d38b652c28
Device Description
Hemostatic agent, including thrombin
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| PMX | Absorbable Collagen Hemostatic Agent With Thrombin | General, Plastic Surgery | 878.4490 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47201 | Collagen haemostatic agent, non-antimicrobial | A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760193182705 | GS1 | ||||
| Package | 13760193182702 | GS1 | Carton | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +33486573610
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P170012 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1.65 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry environment
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius