FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoSphere
DI: 00690103197105
·
Model: HEMRLSTD1000
·
Edwards Lifesciences LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HemoSphere
- Primary DI
- 00690103197105
- Version / Model
- HEMRLSTD1000
- Catalog Number
- HEMRLSTD1000
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-24
- Public Version
- 6
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- ff42f82e-ad61-48d1-b9b2-149c90b1228e
Device Description
HemoSphere Roll Stand
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQE | Catheter, Oximeter, Fiberoptic | Cardiovascular | 870.1230 | 2 |
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42513 | Transportable medical equipment stand, non-powered | A non-powered (non-active) transportable device [e.g., on wheels or easily movable] designed to support medical equipment used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103197105 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163381 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Height: 1118 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place.