FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Medline
DI: 10197344076970
·
Model: DYNDTB2012
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Medline
- Primary DI
- 10197344076970
- Version / Model
- DYNDTB2012
- Catalog Number
- DYNDTB2012
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-23
- Public Version
- 3
- Public Version Date
- 2026-01-28
- Public Version Status
- Update
- Public Device Record Key
- ed247efa-c1ea-4318-a2f9-88fe96a7f661
- Distribution End Date
- 2026-01-27
Device Description
IV ADMIN SET, 20DRP, 2NF, 96
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60822 | Medication transfer needle, filtering/vented | A slender, rigid, sharp or blunt, dual-lumen tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It is designed to puncture the vial septum, aspirate medication and simultaneously allow air into the vial to reduce back-pressure; it has an integral filter intended to prevent the ingress of airborne microbial contaminants. Typically, the proximal end is a Luer connector. The device is sometimes referred to as vent spike. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20197344076977 | GS1 | CS | 50 | Not in Commercial Distribution | 2026-01-27 |
| Primary | 10197344076970 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight, Keep dry, Keep product upright, Protect from freezing, Avoid excessive heat.