FDA UDI
In Commercial Distribution
🇺🇸 United States
Resp-O2 Suction Catheter Kit
DI: 00840117312258
·
Model: 32092
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Resp-O2 Suction Catheter Kit
- Primary DI
- 00840117312258
- Version / Model
- 32092
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 1
- Public Version Date
- 2021-04-30
- Public Version Status
- New
- Public Device Record Key
- 8584328a-4927-4ede-ab8f-98bd04dedd0c
Device Description
Resp-O2 Suction Catheter Kit Adult Graduated Sleeved Catheter, 12FR
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
- No
- 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 |
|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13846 | Secretion suction kit | A collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840117312265 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00840117312258 | GS1 |