Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Medication transfer needle, filtering/vented FDA UDI
- Device Name
- IV ADMIN SET, 15DRP, ROLLER CLAMP, 92 FDA UDI
- Model / Reference
- DYNDTB1537 FDA UDI
- Description
- IV ADMIN SET, 15DRP, ROLLER CLAMP, 92 FDA UDI
Identifiers
- Catalog Number
- DYNDTB1537 FDA UDI
- Primary DI / UDI-DI
- 10197344008247 FDA UDI
- 510(k) Number
- K210381 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Medication transfer needle, filtering/vented FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medication transfer needle, filtering/vented
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medication transfer needle, filtering/vented.
- Vented Vial Adapter Transfer Device — WEST PHARMA. SERVICES IL, . LTD · Class II
- Vented Vial Adapter Transfer Device — WEST PHARMA. SERVICES IL, . LTD · Class II
- Vented Vial Adapter Transfer Device — WEST PHARMA. SERVICES IL, . LTD · Class II
- Vented Vial Adapter Transfer Device — WEST PHARMA. SERVICES IL, . LTD · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K210381 also covers:
- BQ+ — BQ PLUS MEDICAL CO., LTD.
- BQ+ — BQ PLUS MEDICAL CO., LTD.
- BQ+ — BQ PLUS MEDICAL CO., LTD.
- BQ+ — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 85c69204-244c-411d-9c40-6de5c88c9c93 37 fields · synced May 31, 2026