FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Relizorb
DI: 00862205000205
·
Model: 100103
·
Alcresta Therapeutics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
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Basic Information
- Brand Name
- Relizorb
- Primary DI
- 00862205000205
- Version / Model
- 100103
- Company Name
- Alcresta Therapeutics, Inc.
- Labeler DUNS
- 078683247
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2023-10-05
- Public Version Status
- Update
- Public Device Record Key
- c2a80efd-179b-488b-9b65-0e901ee757c1
- Distribution End Date
- 2016-12-31
Device Description
Enzyme Packed Cartridge
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PLQ | Enzyme Packed Cartridge | Gastroenterology, Urology | 876.5985 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62270 | Enteral feed fat-digestion cartridge | A non-sterile, noninvasive device intended to be connected to an enteral feeding tube to digest (i.e., hydrolyse) the fat content in an enteral feeding solution as it passes through the device, typically used for patients unable to produce pancreatic fat digestive enzymes. It is a small plastic housing with connectors that contains a porous filter and the enzyme lipase. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862205000205 | GS1 | ||||
| Package | 20862205000209 | GS1 | Case | 12 | Not in Commercial Distribution | 2016-12-31 |
| Package | 10862205000202 | GS1 | Box | 30 | Not in Commercial Distribution | 2016-12-31 |
| Package | 30862205000206 | GS1 | Box | 10 | Not in Commercial Distribution | 2016-12-31 |
| Package | 40862205000203 | GS1 | Case | 24 | Not in Commercial Distribution | 2016-12-31 |
| Package | 50862205000200 | GS1 | Box | 10 | Not in Commercial Distribution | 2016-12-31 |
| Package | 60862205000207 | GS1 | Case | 24 | Not in Commercial Distribution | 2016-12-31 |
Customer Contacts
- Phone
- 6177149946
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius