FDA UDI
In Commercial Distribution
🇺🇸 United States
Steris
DI: 00628725007397
·
Model: FL2010
·
Canadian Hospital Specialties Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Steris
- Primary DI
- 00628725007397
- Version / Model
- FL2010
- Catalog Number
- FL2010
- Company Name
- Canadian Hospital Specialties Limited
- Labeler DUNS
- 240992693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-23
- Public Version
- 3
- Public Version Date
- 2024-07-01
- Public Version Status
- Update
- Public Device Record Key
- 042765d8-8a91-412a-87b1-827adb518be1
Device Description
INSUFFLATION TUBING, BARB CONNECTOR
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | Obstetrics/Gynecology | 884.1730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60738 | Endoscopic insufflation tubing set, single-use | A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50628725007392 | GS1 | Corrugate Case | 20 | In Commercial Distribution | |
| Primary | 00628725007397 | GS1 |