FDA UDI
In Commercial Distribution
🇺🇸 United States
KC Airway Tape - Long-term
DI: 00860009651630
·
Model: AWLT-200001
·
KelCor, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KC Airway Tape - Long-term
- Primary DI
- 00860009651630
- Version / Model
- AWLT-200001
- Company Name
- KelCor, LLC
- Labeler DUNS
- 081476206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-22
- Public Version
- 1
- Public Version Date
- 2026-01-30
- Public Version Status
- New
- Public Device Record Key
- 9eda29bc-d5a4-4586-8dd5-111286db8f33
Device Description
Adult Airway Tape - Long-term
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | Anesthesiology | 868.5770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58986 | Multi-purpose surgical skin adhesive tape | A long thin band of synthetic material coated on one or both sides with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or a combination of materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009651630 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 80 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 40 – 60 Percent (%) Relative Humidity