FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Curity
DI: 10884527016662
·
Model: 3339
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Curity
- Primary DI
- 10884527016662
- Version / Model
- 3339
- Catalog Number
- 3339
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-27
- Public Version
- 5
- Public Version Date
- 2020-10-12
- Public Version Status
- Update
- Public Device Record Key
- 48fd9eb7-4712-4221-ab8c-6c4d0d85ce91
- Distribution End Date
- 2019-11-14
Device Description
Sodium Chloride Dressing
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KMF | Bandage, liquid | General Hospital | 880.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37298 | Wound irrigation sterile saline | A sterile solution of sodium chloride (NaCl), sometimes with additional compounds, intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and is typically provided in an appropriate container. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884527016669 | GS1 | CASE | 96 | Not in Commercial Distribution | 2019-11-14 |
| Primary | 10884527016662 | GS1 | ||||
| Package | 30884527016666 | GS1 | PACK_OR_INNER_PACK | 24 | Not in Commercial Distribution | 2019-11-14 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.75 | Inch | |
| Width | 6 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;