FDA UDI
In Commercial Distribution
🇺🇸 United States
ASTOTUBE®
DI: 04260114140641
·
Model: IFT30410
·
Stihler Electronic GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ASTOTUBE®
- Primary DI
- 04260114140641
- Version / Model
- IFT30410
- Catalog Number
- IFT30410
- Company Name
- Stihler Electronic GmbH
- Labeler DUNS
- 317742377
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-11
- Public Version
- 4
- Public Version Date
- 2022-10-10
- Public Version Status
- Update
- Public Device Record Key
- a280f91c-c3dc-4e9b-b92b-37ac683e262e
Device Description
PVC infusion extension
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BSB | Warmer, blood, non-electromagnetic radiation | Hematology | 864.9205 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36244 | Electronic gravity infusion controller administration set | A collection of devices designed for the intravenous (IV) administration of fluid from a container, through an automated infusion controller, to a catheter/needle hub or extension tube set at the patient site. The collection typically consists of plastic tubing, a check valve, a roller clamp, a Y-piece connector for secondary tubing attachment, and Luer connectors at both ends. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04260114140436 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 04260114140641 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991160 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry / Protect from Sunlight