FDA UDI
In Commercial Distribution
🇺🇸 United States
Merit® Manifold
DI: 00884450034286
·
Model: 00884450034286
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Merit® Manifold
- Primary DI
- 00884450034286
- Version / Model
- 00884450034286
- Catalog Number
- 503LTCHN-R/C
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2021-10-11
- Public Version Status
- Update
- Public Device Record Key
- 8791e590-d415-4b5f-a572-c2a63b07894d
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| DTL | Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass | Cardiovascular | 870.4290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35375 | Stopcock | A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10884450034283 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00884450034286 | GS1 | ||||
| Package | 20884450034280 | GS1 | 4 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Cable Length-48" (122 cm) | ||
| Device Size Text, specify | Pressure Rating (psi/bar)-500 psi (34 bar) | ||
| Device Size Text, specify | Compensator Tubing (PM6112)-48" (122 cm) |