FDA UDI
In Commercial Distribution
🇺🇸 United States
TEG5000 HEMOSTASIS ANALYZER
DI: 30812747018184
·
Model: 07-022
·
HAEMONETICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TEG5000 HEMOSTASIS ANALYZER
- Primary DI
- 30812747018184
- Version / Model
- 07-022
- Company Name
- HAEMONETICS CORPORATION
- Labeler DUNS
- 057827420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-11
- Public Version
- 4
- Public Version Date
- 2023-10-02
- Public Version Status
- Update
- Public Device Record Key
- 73837786-3f91-4cc7-9ab2-23f00f21347e
Device Description
TEG ANALYZER, 5000, 120V, 60HZ, FG
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66878 | Blood viscoelasticity analyser IVD | An electrically-powered laboratory instrument intended to be used for the determination of blood rheological properties (thromboelastography), namely blood viscosity and elasticity, in a whole blood specimen. Its principle of operation is based on detection of blood resistance changes upon vibrations of a resonating probe. The device is typically used in the evaluation of the functional state of haemostasis in patients with haemostatic disorders or haemorrhagic complications, or who are receiving antithrombotic or anticoagulant therapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30812747018184 | GS1 |
Customer Contacts
- Phone
- +1(800)-537-2802
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993678 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pressure | 60 | Hertz |