FDA UDI
In Commercial Distribution
🇺🇸 United States
H.E.L.P.®
DI: 04046964699467
·
Model: 7061192
·
B.Braun Avitum AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
80
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Basic Information
- Brand Name
- H.E.L.P.®
- Primary DI
- 04046964699467
- Version / Model
- 7061192
- Catalog Number
- 7061192
- Company Name
- B.Braun Avitum AG
- Labeler DUNS
- 343689704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 80
- Record Status
- Published
- Publish Date
- 2016-03-09
- Public Version
- 6
- Public Version Date
- 2019-09-12
- Public Version Status
- Update
- Public Device Record Key
- fb08f074-0693-4419-a1fa-aac607d9c9ee
Device Description
HELP HEPARIN 400,000 IU V 50/40ML US
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
- No
- 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 |
|---|---|---|---|---|
| MMY | LIPOPROTEIN, LOW DENSITY, REMOVAL | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58091 | Apheresis kit | A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform (connect the patient) an apheresis treatment (e.g., immunoadsorption, plasmapheresis, plasma exchange) with an apheresis system. It typically consists of tubing, separation devices (e.g., adsorber, filter), and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964699467 | GS1 | ||||
| Unit of Use | 04046955348367 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P940016 | 000 |
| P940016 | 016 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Volume : 40.000 ML | ||
| Device Size Text, specify | Concentration (IU/ml) : 10000.000 IE3 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius