FDA UDI
In Commercial Distribution
🇺🇸 United States
AincA®
DI: B005E13530
·
Model: E-135-3
·
ANESTHESIA ASSOCIATES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AincA®
- Primary DI
- B005E13530
- Version / Model
- E-135-3
- Catalog Number
- E-135-3
- Company Name
- ANESTHESIA ASSOCIATES, INC.
- Labeler DUNS
- 002065670
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-31
- Public Version
- 1
- Public Version Date
- 2021-04-08
- Public Version Status
- New
- Public Device Record Key
- 3444aa87-5401-498b-adab-ab7c31565b60
Device Description
Mask, BOC Type, Inflatable Cuff Seal, 22mmF, Size 3 Small, w/Hook Ring, Conductive Neoprene w/ Latex
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| BSJ | MASK, GAS, ANESTHETIC | Anesthesiology | 868.5550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35176 | Anaesthesia face mask, reusable | A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B005E13530 | HIBCC |
Customer Contacts
- Phone
- +1(760)744-6561
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3 |