FDA UDI
In Commercial Distribution
🇺🇸 United States
Capette™
DI: 10889483228579
·
Model: CP-4201
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Capette™
- Primary DI
- 10889483228579
- Version / Model
- CP-4201
- Catalog Number
- CP-4201
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-31
- Public Version
- 2
- Public Version Date
- 2026-03-03
- Public Version Status
- Update
- Public Device Record Key
- 1cf08c36-d8fd-4f40-ba03-c9dbfda39dbc
Device Description
Small Capette™ with Small Tube Tackles
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAY | Support, Breathing Tube | Anesthesiology | 868.5280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64491 | Medical/surgical interventional tube/cable securement strap | A strip of material in the form of tape/strap intended to be used to secure interventional patient tubes/cables to drapes or device covers in surgical/medical settings; it is not intended to attach to the patient and has no additional intended uses. It may be comprised of, e.g., an adhesive on one side to allow attachment to a drape/cover and Velcro on the other side for securing tubing/cables. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20889483228576 | GS1 | Box | 40 | In Commercial Distribution | |
| Primary | 10889483228579 | GS1 | ||||
| Previous | 00709078012990 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]