FDA UDI
In Commercial Distribution
🇺🇸 United States
HNM Medical
DI: 00841742149356
·
Model: HNM-45-002
·
HNM STAINLESS, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- HNM Medical
- Primary DI
- 00841742149356
- Version / Model
- HNM-45-002
- Catalog Number
- HNM-45-002
- Company Name
- HNM STAINLESS, LLC.
- Labeler DUNS
- 806754185
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-27
- Public Version
- 2
- Public Version Date
- 2025-07-08
- Public Version Status
- Update
- Public Device Record Key
- d9471b1d-ae59-41d2-9008-8533516650b6
Device Description
Drop Cardiac Adult Suction Tube
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
- Yes
- 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 |
|---|---|---|---|---|
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | Cardiovascular | 870.4420 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35441 | Cardiopulmonary bypass system blood tubing set | A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10841742149353 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 00841742149356 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Drop Cardiac Infant Suction Tube Kit |