FDA UDI
In Commercial Distribution
🇺🇸 United States
RUSCH
DI: 14026704641533
·
Model: IPN049976
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- RUSCH
- Primary DI
- 14026704641533
- Version / Model
- IPN049976
- Catalog Number
- 9912001
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-24
- Public Version
- 3
- Public Version Date
- 2023-07-19
- Public Version Status
- Update
- Public Device Record Key
- 1e7eb85f-8b1c-4682-958e-1b9d870b12a2
Device Description
HEAD HARNESS - ADULT
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
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| BTK | STRAP, HEAD, GAS MASK | Anesthesiology | 868.5560 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60882 | Anaesthesia mask strap, single-use | A non-sterile, non-latex strap/head harness intended to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and affixed to the mask. It is typically used for anaesthesia of long duration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 34026704641537 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 14026704641533 | GS1 | ||||
| Previous | 04026704544677 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]