FDA UDI
In Commercial Distribution
🇺🇸 United States
BloodSTOP iX
DI: 00850744001265
·
Model: BS-iX-17
·
Lifescience Plus, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- BloodSTOP iX
- Primary DI
- 00850744001265
- Version / Model
- BS-iX-17
- Catalog Number
- BS-iX-17
- Company Name
- Lifescience Plus, Inc.
- Labeler DUNS
- 190600051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 3
- Public Version Date
- 2024-01-15
- Public Version Status
- Update
- Public Device Record Key
- 03ce5b14-cede-43c3-9383-781ebe644a9b
Device Description
BloodSTOP iX Hemostat surgical 4"X8" ( 10cmX20cm)
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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58059 | Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial | A non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. 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 | 10850744001262 | GS1 | ||||
| Primary | 00850744001265 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 32 | Square inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius