FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgiphor
DI: 00382909101201
·
Model: 910120
·
CAREFUSION 2200, INC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Surgiphor
- Primary DI
- 00382909101201
- Version / Model
- 910120
- Catalog Number
- 910120
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-05
- Public Version
- 1
- Public Version Date
- 2026-03-13
- Public Version Status
- New
- Public Device Record Key
- 026e6953-b0c5-42f7-8ed1-2fa273ad7bb6
Device Description
BD Surgiphor 1000 mL Antimicrobial Irrigation System
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
- 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 |
|---|---|---|---|---|
| FQH | LAVAGE, JET | General Hospital | 880.5475 | 2 |
| FRO | Dressing, wound, drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62394 | Pressure-regulated wound irrigation solution applicator, manual | A hand-held manual device in the form of a compressible bottle with a specialized nozzle, intended to be used to apply a pressure-regulated jet stream of non-medicated topical solution (e.g., sterile water, saline) to mechanically irrigate, clean/moisten, and decontaminate a wound. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50382909101206 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 00382909101201 | GS1 |
Customer Contacts
- Phone
- +1(844)823-5433
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K253445 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid freezing or heating above 40DEG C (104DEG F), store at room temperature