Identity
- Trade Name
- Custom Medical Specialties, Inc. FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- Single Spike Infiltration Tubing FDA UDI
- Model / Reference
- CMS-1270 FDA UDI
- Description
- Single Spike Infiltration Tubing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815849024717 FDA UDI
- 510(k) Number
- K993463 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive 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
No
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: Basic intravenous administration set, noninvasive
Custom Medical Specialties, Inc. by Custom Assemblies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic intravenous administration set, noninvasive.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- IMED — BQ PLUS MEDICAL CO., LTD. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- Kew Medical — DOUGLAS MEDICAL PRODUCTS, INC · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K993463 also covers:
- Custom Medical Specialties — CUSTOM ASSEMBLIES, INC.
- Custom Medical Specialties, Inc. — CUSTOM ASSEMBLIES, INC.
- Custom Medical Specialties, Inc. — CUSTOM ASSEMBLIES, INC.
- PG-1000 — CUSTOM ASSEMBLIES, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Custom Assemblies, Inc.
Sources (1)
- FDA UDI 0b2a39e1-8acf-4409-8bdc-037f2651192b 34 fields · synced Jun 8, 2026