FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10080196997411
·
Model: DYND44108
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10080196997411
- Version / Model
- DYND44108
- Catalog Number
- DYND44108
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-28
- Public Version
- 2
- Public Version Date
- 2021-07-22
- Public Version Status
- Update
- Public Device Record Key
- 2de7426b-5b0f-4ffe-9830-9e423aee0c69
Device Description
TRAP,MUCUS,8FR,DELEE,W/VALVE
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
- 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 |
|---|---|---|---|---|
| BYZ | TRAP, STERILE SPECIMEN | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62853 | Oropharyngeal secretion specimen suction kit | A collection of devices intended exclusively for professional use to obtain by suction a mucus/sputum specimen from the oropharynx of a neonate for microbiological examination; it might in addition be used to clear mucus from the oropharynx to assist respiration. It consists of a catheter/tube intended to be inserted orally, a piece of suction tubing intended to be attached to an appropriate pump (not included), an empty specimen collection container, and appropriate adapters/lids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40080196715542 | GS1 | CARTON | 50 | In Commercial Distribution | |
| Primary | 10080196997411 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8 | French |