FDA UDI
In Commercial Distribution
🇺🇸 United States
Tech Medical Services
DI: 00851695005265
·
Model: TM500D
·
TECHMEDICAL SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Tech Medical Services
- Primary DI
- 00851695005265
- Version / Model
- TM500D
- Company Name
- TECHMEDICAL SERVICES, INC.
- Labeler DUNS
- 556093219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2f8d1c85-8f85-4892-9111-2dee2c14f099
Device Description
Scope warmer which pre-warms multiple endoscopes
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
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NWV | Laparoscopic Accessories, Gynecologic | Obstetrics/Gynecology | 884.1720 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36816 | Instrument warmer, electric | An electrically-powered heating device intended to warm patient-contact instruments (e.g., rigid endoscopes or trocars) before they are introduced into body orifices or other parts of the body. It typically consists of a tabletop device that has recesses or wells for placement of the instrument insertion portion, a heating element, a thermostat and operating controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10851695005262 | GS1 | Inner Pack | 10 | In Commercial Distribution | |
| Primary | 00851695005265 | GS1 |